(168 days)
Not Found
No
The document describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an anterior cervical plate system intended for surgical fixation, not a therapeutic device in the sense of delivering a therapy (e.g., medication, energy, or rehabilitation).
No
The device is described as an anterior cervical plate system for screw fixation to the cervical spine, intended for treatment of various spinal conditions. It is a surgical implant, not a diagnostic tool used to identify or analyze diseases.
No
The device description clearly states it is an anterior cervical plate system made of titanium alloy, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ASSURE® Anterior Cervical Plate System is a surgical implant designed for fixation of the cervical spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the ASSURE® Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes
KWQ
Device Description
ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical testing (static and dynamic compression bending, and static torsion) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K040721, K121049, K133567, K050813
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183056
Device Name ASSURE® Anterior Cervical Plate System
Indications for Use (Describe)
The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
| 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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April 19, 2019
Globus Medical, Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K183056
Trade/Device Name: ASSURE® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 26, 2019 Received: March 27, 2019
Dear Dr. Baker:
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
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Summary: ASSURE-T Anterior Cervical Plate
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
| ---------- | ----------------------------------------------------------------------------------------- |
|---|
- Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- Date Prepared: October 31, 2018
- Device Name: ASSURE® Anterior Cervical Plate System
- Anterior Cervical Plate System Common Name:
- Per 21 CFR as follows: Classification: §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II, Panel Code: 87
Primary Predicate: ASSURE® (K040721)
Additional
Predicates: UNIFY® (K121049, K133567) Aesculap ABC2 (K050813)
Purpose:
The purpose of this 510(k) is to request clearance for the ASSURE®-T Translational Anterior Cervical Plates, a modification of the predicate ASSURE® Anterior Cervical Plate System.
Device Description:
ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
Indications for Use:
The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scollosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
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Technological Characteristics:
ASSURE®-T implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Performance Data:
Mechanical testing (static and dynamic compression bending, and static torsion) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Basis of Substantial Equivalence:
The ASSURE®-T Translational Anterior Cervical Plate has been found to be substantially equivalent to the predicates with respect to technological characteristics, performance, design, materials, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.