FDA 510(k)

Inset Reverse Total Shoulder System

Número K: K252221 · 2025-09-26

Data da decisão2025-09-26

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Inset Reverse Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K252221. 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 Inset Reverse Total Shoulder System?

Inset Reverse Total Shoulder System is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K252221.

When did Inset Reverse Total Shoulder System receive FDA 510(k) clearance?

Inset Reverse Total Shoulder System received FDA 510(k) clearance on 2025-09-26, under 510(k) number K252221.

Who is the listed applicant for Inset Reverse Total Shoulder System?

The FDA 510(k) record lists Shoulder Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inset Reverse Total Shoulder System?

The FDA product code for Inset Reverse Total Shoulder System is PHX.

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Outros registros que listam Shoulder Innovations, Inc. como candidato(a)

K262173N22 Offset Humeral Head K254128InSet Reverse Total Shoulder System K252516N22 EZ Glenosphere K241817InSet Total Shoulder System K213615Shoulder Innovations Total Shoulder System K210533Inset Reverse Total Shoulder System

Ver todos os 9 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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