Class Class II
Omnia Medical Coupler-C Anterior Cervical Plate (K223321)
Description
Omnia Medical Coupler-C Anterior Cervical Plate by Omnia Medical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223321
Clearance Date2023-03-13
Clearance TypeTraditional
Product CodeKWQ
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223321
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Omnia Medical Coupler-C Anterior Cervical Plate (K223321) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183056 | ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. | 2019 |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | 2019 |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer D... | Zimmer Spine, Inc. | 2015 |
| K113329 | K2M, PYRENEES CERVICAL PLATE SYSTEM | K2m, Inc. | 2012 |
Trace the full predicate network for K223321
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.