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FDA 510(k)

3DMetal Diaphyseal Femoral Cones

K-Number: K200075 · 2020-03-13

Decision Date2020-03-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3DMetal Diaphyseal Femoral Cones is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-03-13 under approval number K200075. 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 3DMetal Diaphyseal Femoral Cones?

3DMetal Diaphyseal Femoral Cones is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Medacta International S.A.. The 510(k) number is K200075.

When was 3DMetal Diaphyseal Femoral Cones approved by the FDA?

3DMetal Diaphyseal Femoral Cones received FDA 510(k) clearance on 2020-03-13, under approval number K200075.

What company makes 3DMetal Diaphyseal Femoral Cones?

3DMetal Diaphyseal Femoral Cones is manufactured by Medacta International S.A..

What is the FDA product code for 3DMetal Diaphyseal Femoral Cones?

The FDA product code for 3DMetal Diaphyseal Femoral Cones is JWH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.