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FDA 510(k)

Pinehurst Anterior Cervical Plate System

K-Number: K181190 · 2019-01-17

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-01-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pinehurst Anterior Cervical Plate System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-01-17 under approval number K181190. 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 Pinehurst Anterior Cervical Plate System?

Pinehurst Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K181190.

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

Pinehurst Anterior Cervical Plate System received FDA 510(k) clearance on 2019-01-17, under approval number K181190.

What company makes Pinehurst Anterior Cervical Plate System?

Pinehurst Anterior Cervical Plate System is manufactured by Signature Orthopaedics Pty, Ltd..

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

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

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Related Devices (Code: 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.

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