FDA 510(k)

Comprehensive Shoulder System

Número K: K193038 · 2020-10-28

Data da decisão2020-10-28

Código do produtoMBF

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comprehensive Shoulder System 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 2020-10-28 under 510(k) number K193038. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Comprehensive Shoulder System?

Comprehensive Shoulder System is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K193038.

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

Comprehensive Shoulder System received FDA 510(k) clearance on 2020-10-28, under 510(k) number K193038.

Who is the listed applicant for Comprehensive Shoulder System?

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 Shoulder System?

The FDA product code for Comprehensive Shoulder System is MBF.

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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 K182516Comprehensive Nano Stemless Shoulder K181611Comprehensive Reverse Shoulder System

Ver todos os 15 dispositivos →

Dispositivos Relacionados (Código: MBF)

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

Fonte oficial

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