FDA 510(k)

Insignia Anterior Cervical Plate System

K-Number: K200995 · 2020-05-21

Decision Date2020-05-21

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Insignia Anterior Cervical Plate System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2020-05-21 under approval number K200995. 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 Insignia Anterior Cervical Plate System?

Insignia Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K200995.

When was Insignia Anterior Cervical Plate System approved by the FDA?

Insignia Anterior Cervical Plate System received FDA 510(k) clearance on 2020-05-21, under approval number K200995.

What company makes Insignia Anterior Cervical Plate System?

Insignia Anterior Cervical Plate System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Insignia Anterior Cervical Plate System?

The FDA product code for Insignia Anterior Cervical Plate System is KWQ.

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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.