FDA 510(k)

Comprehensive Nano Stemless Shoulder

Número K: K182516 · 2019-04-22

Data da decisão2019-04-22

Código do produtoPKC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comprehensive Nano Stemless Shoulder 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 2019-04-22 under 510(k) number K182516. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Comprehensive Nano Stemless Shoulder?

Comprehensive Nano Stemless Shoulder is a medical device that received FDA 510(k) clearance on 2019-04-22. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K182516.

When did Comprehensive Nano Stemless Shoulder receive FDA 510(k) clearance?

Comprehensive Nano Stemless Shoulder received FDA 510(k) clearance on 2019-04-22, under 510(k) number K182516.

Who is the listed applicant for Comprehensive Nano Stemless Shoulder?

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 Comprehensive Nano Stemless Shoulder?

The FDA product code for Comprehensive Nano Stemless Shoulder is PKC.

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Outros registros que listam Biomet Manufacturing Corp como candidato(a)

K230540Patient Specific Planning Solution™ 3D Bone Models K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner K202232Comprehensive Vault Reconstruction System K193038Comprehensive Shoulder System K181611Comprehensive Reverse Shoulder System

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Dispositivos Relacionados (Código: PKC)

K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129Prótese de Humeral AETOS Shoulder System Sem CabeçaSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716Prótese de Humeral AETOS Shoulder System Sem CabeçaSmith & Nephew, Inc.

Fonte oficial

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