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FDA 510(k)

Exactech® Equinoxe® Laser Cage Glenoid

K-Number: K212356 · 2022-03-04

ApplicantExactech, Inc.
Decision Date2022-03-04
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Laser Cage Glenoid is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2022-03-04 under approval number K212356. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Equinoxe® Laser Cage Glenoid?

Exactech® Equinoxe® Laser Cage Glenoid is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Exactech, Inc.. The 510(k) number is K212356.

When was Exactech® Equinoxe® Laser Cage Glenoid approved by the FDA?

Exactech® Equinoxe® Laser Cage Glenoid received FDA 510(k) clearance on 2022-03-04, under approval number K212356.

What company makes Exactech® Equinoxe® Laser Cage Glenoid?

Exactech® Equinoxe® Laser Cage Glenoid is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Equinoxe® Laser Cage Glenoid?

The FDA product code for Exactech® Equinoxe® Laser Cage Glenoid is KWS.

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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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