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FDA 510(k)

Proficient™ Posterior Cervical Spine System

K-Number: K162639 · 2017-02-07

Decision Date2017-02-07
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Proficient™ Posterior Cervical Spine System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-02-07 under approval number K162639. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proficient™ Posterior Cervical Spine System?

Proficient™ Posterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Spine Wave, Inc.. The 510(k) number is K162639.

When was Proficient™ Posterior Cervical Spine System approved by the FDA?

Proficient™ Posterior Cervical Spine System received FDA 510(k) clearance on 2017-02-07, under approval number K162639.

What company makes Proficient™ Posterior Cervical Spine System?

Proficient™ Posterior Cervical Spine System is manufactured by Spine Wave, Inc..

What is the FDA product code for Proficient™ Posterior Cervical Spine System?

The FDA product code for Proficient™ Posterior Cervical Spine System is NKG.

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Official Source

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