FDA 510(k)

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

Número K: K241491 · 2024-10-10

RequerenteStryker Corporation (Tornier, S.A.S.)

Data da decisão2024-10-10

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, S.A.S.). It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K241491. 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 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K241491.

When did Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid receive FDA 510(k) clearance?

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid received FDA 510(k) clearance on 2024-10-10, under 510(k) number K241491.

Who is the listed applicant for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

The FDA 510(k) record lists Stryker Corporation (Tornier, S.A.S.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

The FDA product code for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is PHX.

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Outros registros que listam Stryker Corporation (Tornier, S.A.S.) como candidato(a)

K253674Blueprint Patient-Specific Instrumentation

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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