Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965)
Description
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) by Alphatec Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
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Predicate lineage for K251965
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. Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody Syste... | Alphatec Spine, Inc. | 2024 |
| K213443 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2021 |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | 2021 |
| K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 |
Trace the full predicate network for K251965
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.