FDA 510(k)

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

Número K: K220731 · 2022-08-11

Data da decisão2022-08-11

Código do produtoMEH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K220731. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem?

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Stryker. The 510(k) number is K220731.

When did Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem receive FDA 510(k) clearance?

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220731.

Who is the listed applicant for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem?

The FDA product code for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is MEH.

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Fonte oficial

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