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FDA 510(k)

GMK Spherika Femurs and Fixed Tibial Trays Plus

K-Number: K211004 · 2021-05-13

ApplicantMedacta International S.A.
Decision Date2021-05-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Spherika Femurs and Fixed Tibial Trays Plus is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-05-13 under approval number K211004. 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 Spherika Femurs and Fixed Tibial Trays Plus?

GMK Spherika Femurs and Fixed Tibial Trays Plus is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Medacta International S.A.. The 510(k) number is K211004.

When was GMK Spherika Femurs and Fixed Tibial Trays Plus approved by the FDA?

GMK Spherika Femurs and Fixed Tibial Trays Plus received FDA 510(k) clearance on 2021-05-13, under approval number K211004.

What company makes GMK Spherika Femurs and Fixed Tibial Trays Plus?

GMK Spherika Femurs and Fixed Tibial Trays Plus is manufactured by Medacta International S.A..

What is the FDA product code for GMK Spherika Femurs and Fixed Tibial Trays Plus?

The FDA product code for GMK Spherika Femurs and Fixed Tibial Trays Plus is JWH.

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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.

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