FDA 510(k)

Tibial baseplate, Tibial insert

Número K: K222700 · 2022-10-06

Data da decisão2022-10-06

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tibial baseplate, Tibial insert is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K222700. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tibial baseplate, Tibial insert?

Tibial baseplate, Tibial insert is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is United Orthopedic Corporation. The 510(k) number is K222700.

When did Tibial baseplate, Tibial insert receive FDA 510(k) clearance?

Tibial baseplate, Tibial insert received FDA 510(k) clearance on 2022-10-06, under 510(k) number K222700.

Who is the listed applicant for Tibial baseplate, Tibial insert?

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

What is the FDA product code for Tibial baseplate, Tibial insert?

The FDA product code for Tibial baseplate, Tibial insert is JWH.

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Fonte oficial

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