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FDA 510(k)

Kestrel™ Buttress Plate System

K-Number: K181063 · 2018-07-13

ApplicantInnovasis, Inc.
Decision Date2018-07-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kestrel™ Buttress Plate System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2018-07-13 under approval number K181063. 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 Kestrel™ Buttress Plate System?

Kestrel™ Buttress Plate System is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Innovasis, Inc.. The 510(k) number is K181063.

When was Kestrel™ Buttress Plate System approved by the FDA?

Kestrel™ Buttress Plate System received FDA 510(k) clearance on 2018-07-13, under approval number K181063.

What company makes Kestrel™ Buttress Plate System?

Kestrel™ Buttress Plate System is manufactured by Innovasis, Inc..

What is the FDA product code for Kestrel™ Buttress Plate System?

The FDA product code for Kestrel™ Buttress Plate System is KWQ.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING

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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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