FDA 510(k)

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System

Número K: K214001 · 2023-03-15

Data da decisão2023-03-15

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comprehensive® Shoulder System, Comprehensive® Reverse 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 2023-03-15 under 510(k) number K214001. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K214001.

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

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System received FDA 510(k) clearance on 2023-03-15, under 510(k) number K214001.

Who is the listed applicant for Comprehensive® Shoulder System, Comprehensive® Reverse 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, Comprehensive® Reverse Shoulder System?

The FDA product code for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is PHX.

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

K230540Patient Specific Planning Solution™ 3D Bone Models K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner K202232Comprehensive Vault Reconstruction System K193038Comprehensive Shoulder System K182516Comprehensive Nano Stemless Shoulder K181611Comprehensive Reverse Shoulder System

Ver todos os 15 dispositivos →

Dispositivos Relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid e Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Fonte oficial

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