SeaSpine Meridian System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian System interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.
No-Profile Implants w/ Screws:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No-Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
SeaSpine Regatta Lateral System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Device Description

The Seaspine Meridian and SeaSpine Regatta Lateral Systems are intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The implants are manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) or titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. Both the Meridian and Regatta interbodies have the ability to accept an anterior or lateral faceplate and offer various configurations that can be used with bone screws or inline fixation, locking covers and an optional spin plate. The instruments included with the system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided text is a 510(k) summary for the SeaSpine Meridian System and SeaSpine Regatta Lateral System, which are intervertebral body fusion devices. This type of FDA submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance, primarily through non-clinical (mechanical) testing. It does not involve AI/ML components or clinical studies with human readers or image interpretation.

Therefore, many of the specific questions regarding AI device performance criteria, human reader studies, and ground truth establishment are not applicable to this document.

However, based on the information provided, here's a description of the acceptance criteria and study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table with specific quantitative acceptance criteria or detailed numerical performance results from the non-clinical tests. Instead, it broadly states that the device's mechanical performance in various tests "effectively demonstrates substantial equivalence" to the predicate devices. The implicit acceptance criterion for a 510(k) submission is that the new device performs as safely and effectively as legally marketed predicate devices.

The reported device performance is that the testing performed demonstrated the new systems are:

"as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate."

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the number of individual devices or components tested in each mechanical test. Mechanical testing typically involves a set number of samples per test type (e.g., n=5 or n=6 per group) to ensure statistical validity, but these exact numbers are not provided.
Data Provenance: The tests are "non-clinical testing" and are performed in a laboratory setting, not on patient data. Thus, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense. The provenance is internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the document describes mechanical testing of physical devices, not image analysis or diagnostic performance where expert ground truth would be required.

4. Adjudication method for the test set:

This question is not applicable for the same reason as above. Mechanical tests are typically evaluated against engineering specifications, not expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. The device is an intervertebral body fusion device, not an AI-powered diagnostic tool. No human reader studies or AI assistance are involved.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics mandated by the relevant ASTM standards (e.g., F2077 for compression, F2267 for subsidence) and the established performance of the predicate devices. The goal is to show comparable or better performance against these established benchmarks.

8. The sample size for the training set:

This question is not applicable as there is no AI algorithm being trained.

9. How the ground truth for the training set was established:

This question is not applicable as there is no AI algorithm being trained.

Summary of Study (Non-Clinical Testing):

The study conducted to demonstrate the device meets acceptance criteria (i.e., substantial equivalence) involves a series of non-clinical, benchtop mechanical tests in accordance with established ASTM (American Society for Testing and Materials) standards.

Specifically, these tests include:

Compression and Compression-Shear Testing: Performed per ASTM F2077.
Subsidence Testing: Performed per ASTM F2267.
Wear Testing: Performed per ASTM F1877.
Expulsion Testing
Static Screw Pushout Testing
Packaging, Shipping, and Sterilization Tests: To validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier.
Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.

The conclusion drawn from these tests is that the new systems are mechanically similar to the predicate devices and perform comparably, thereby demonstrating that they are as safe and effective. The acceptance criteria are implicitly met by demonstrating that the new devices' performance falls within acceptable ranges when compared to predicate devices and relevant industry standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

June 10, 2020

SeaSpine Orthopedics Corporation Aly Alvarez Sr. Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K200879

Trade/Device Name: SeaSpine Meridian System, SeaSpine Regatta Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: March 31, 2020 Received: April 2, 2020

Dear Ms. Alvarez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200879

Device Name

SeaSpine Meridian System and SeaSpine Regatta Lateral System

Indications for Use (Describe) SeaSpine Meridian System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Meridian System interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.

No-Profile Implants w/ Screws:

The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No-Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

SeaSpine Regatta Lateral System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with

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degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5622
Fax number:	(760) 683-6874
Contact person:	Aly Alvarez, Sr. Regulatory Affairs Specialist
Date Prepared:	March 30, 2020
Device Name
Trade Name:	1. SeaSpine Meridian System2. SeaSpine Regatta Lateral System
Common Name:	Intervertebral Body Fusion Device

Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar (21 CFR 888.3080)

Class: ll

Product Code: MAX; OVD

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K101310	OVD	SeaSpine Vu a•PODIntervertebral Body FusionDevice	SeaSpine OrthopedicsCorporation (formerlyTheken Spine)
Additional Predicate Device
K162351	OVD	SeaSpine Vu a•POD PrimeNanoMetalene IntervertebralBody Fusion Device	SeaSpine OrthopedicsCorporation
K181079	MAX	Regatta Lateral System	SeaSpine OrthopedicsCorporation
Reference Predicate Device
K200885	KWQ	Meridian Anterior Plate System,Regatta Lateral Plate System	SeaSpine OrthopedicsCorporation

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Device Description

Intended Use/Indications for Use

Meridian System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

No-Profile Implants w/ Screws:

The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

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and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

Regatta Lateral System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

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Summary of Technological Characteristics

The SeaSpine Meridian System and SeaSpine Regatta System is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, manufacturing, etc.) and performance (mechanical safety).

The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.

Non-Clinical Testing

Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), wear testing (ASTM F1877), expulsion, and static screw pushout was performed. Packaging, shipping and sterilization tests was also conducted to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST- 72:2011.

Conclusions

The submitted data demonstrates that the SeaSpine Meridian System and SeaSpine Regatta Lateral System is each as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.