The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:

· Fracture (including dislocation and subluxation)
• Tumor

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Pseudoarthrosis
· Spondylolysis
· Spondylolisthesis
· Scoliosis
· Lordotic deformities of the spine
· Spinal stenosis
· Failed previous spine surgery

Device Description

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Z-Span Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria or a study proving that a software device meets acceptance criteria. Instead, it focuses on the Z-Span Plate System, which is an implantable orthopedic device for spinal fixation. The "Performance Data" section specifically mentions mechanical testing (static and dynamic axial compression bending testing and static torsion testing) according to ASTM F1717, which is relevant for the physical properties of surgical implants, not for the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for a software device, its reported performance, sample sizes, ground truth establishment, or expert adjudication. The document pertains to a physical medical implant, not a software device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Zavation Medical Products LLC Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

November 4, 2020

Re: K202624

Trade/Device Name: Z-Span Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 9, 2020 Received: September 10, 2020

Dear Frankie Cummins:

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 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

{1}------------------------------------------------

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 medical devices and radiation-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,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202624

Device Name

Z-Span Plate System

Indications for Use (Describe)

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:

· Fracture (including dislocation and subluxation)
• Tumor

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Pseudoarthrosis
· Spondylolysis
· Spondylolisthesis
· Scoliosis
· Lordotic deformities of the spine
· Spinal stenosis
· Failed previous spine surgery

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K Summary

Date:	Nov 3, 2020
Submitter:	Zavation, Medical Products LLC220 Lakeland ParkwayFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Frankie Cummins
Type of 510(k) submission:	Traditional
Trade name:	Z-Span Plate System
Common Name:	Spinal Fixation System
Classification regulation/code:	888.3060, KWQ
Classification name:	Spinal Intervertebral Body Fixation Orthosis
Device classification:	Class II
Classification Panel:	Orthopedic
Basis for submission:	Addition of components: added expanding lateral plateoptions

Device Description:

Indications for Use:

{4}------------------------------------------------

The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

Fracture (including dislocation and subluxation) ●
. Tumor
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Scoliosis
Lordotic deformities of the spine
Spinal stenosis
Failed previous spine surgery

Predicate Device:

Zavation, Z-Span Plate System (K162824) Primary:

Additional: Synthes, Anterior Thoracolumbar Locking Plate (K020244) Zavation, Z-Span Plate System (K160362) Zavation, Zavation Spinal System (K112484)

Technological Characteristics:

The technological characteristics including material, design, performance, intended use, and indications for use of the Z-Span Plate System are consistent with those of the predicate devices.

Performance Data:

Mechanical testing of the Z-Span Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717. Test results demonstrate that the Z-Span Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate devices.

Conclusion:

Based on the similarities in materials, design, principles of function, intended use and indications, the Z-Span Plate system has been shown to be substantially equivalent to the predicate devices. Non-clinical data demonstrates the Z-Span Plate System performs as well as the predicate devices. The Z-Span Plate System does not raise new issues of safety or effectiveness questions.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.