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FDA 510(k)

SMR Stemless Anatomic

K-Number: K221758 · 2023-03-17

Decision Date2023-03-17
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Stemless Anatomic is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2023-03-17 under approval number K221758. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR Stemless Anatomic?

SMR Stemless Anatomic is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K221758.

When was SMR Stemless Anatomic approved by the FDA?

SMR Stemless Anatomic received FDA 510(k) clearance on 2023-03-17, under approval number K221758.

What company makes SMR Stemless Anatomic?

SMR Stemless Anatomic is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR Stemless Anatomic?

The FDA product code for SMR Stemless Anatomic is PKC.

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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.