FDA 510(k)

GMK Sphere Revision

K-Number: K211664 · 2021-07-29

Decision Date2021-07-29

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GMK Sphere Revision is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-07-29 under approval number K211664. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK Sphere Revision?

GMK Sphere Revision is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by Medacta International S.A.. The 510(k) number is K211664.

When was GMK Sphere Revision approved by the FDA?

GMK Sphere Revision received FDA 510(k) clearance on 2021-07-29, under approval number K211664.

What company makes GMK Sphere Revision?

GMK Sphere Revision is manufactured by Medacta International S.A..

What is the FDA product code for GMK Sphere Revision?

The FDA product code for GMK Sphere Revision is JWH.

Other Devices by Medacta International S.A.

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Related Devices (Code: JWH)

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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.