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FDA PMA

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing

Número do PMA: P010014 · 2026-09-01

RequerenteBiomet Manufacturing Corp
Data da decisão2026-09-01
Número PMAP010014
Código do produtoNRA
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOR

Resumo do dispositivo

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code NRA. It was reviewed by the OR advisory panel.

Perguntas frequentes

What is the Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing?

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Biomet Manufacturing Corp.

When did Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing receive FDA 510(k) clearance?

The clearance date for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing can be found in the official FDA records.

Who is the listed applicant for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing?

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

What is the FDA product code for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing?

The FDA product code for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is NRA.

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Fonte oficial

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