FDA 510(k)

Blueprint Patient-Specific Instrumentation

Número K: K253674 · 2026-04-03

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

Data da decisão2026-04-03

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blueprint Patient-Specific Instrumentation 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 2026-04-03 under 510(k) number K253674. 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?

Blueprint Patient-Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K253674.

When did Blueprint Patient-Specific Instrumentation receive FDA 510(k) clearance?

Blueprint Patient-Specific Instrumentation received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253674.

Who is the listed applicant for Blueprint Patient-Specific Instrumentation?

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?

The FDA product code for Blueprint Patient-Specific Instrumentation is PHX.

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

K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

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Fonte oficial

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