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FDA 510(k)

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

K-Number: K251965 · 2025-08-28

ApplicantAlphatec Spine, Inc.
Decision Date2025-08-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-08-28 under approval number K251965. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K251965.

When was Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) approved by the FDA?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) received FDA 510(k) clearance on 2025-08-28, under approval number K251965.

What company makes Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

The FDA product code for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is KWQ.

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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