FDA 510(k)

Restoration Anatomic Shell

Número K: K210893 · 2021-04-22

RequerenteHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Data da decisão2021-04-22

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Restoration Anatomic Shell is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K210893. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Restoration Anatomic Shell?

Restoration Anatomic Shell is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K210893.

When did Restoration Anatomic Shell receive FDA 510(k) clearance?

Restoration Anatomic Shell received FDA 510(k) clearance on 2021-04-22, under 510(k) number K210893.

Who is the listed applicant for Restoration Anatomic Shell?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Restoration Anatomic Shell?

The FDA product code for Restoration Anatomic Shell is LPH.

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