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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 the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) 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. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K251965.

When did Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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