FDA 510(k)

Tornier Humeral Nail and Tornier Long Humeral Nail

N.º K: K230352 · 2023-10-31

Fecha de decisión2023-10-31

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tornier Humeral Nail and Tornier Long Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K230352. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tornier Humeral Nail and Tornier Long Humeral Nail?

Tornier Humeral Nail and Tornier Long Humeral Nail is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Tornier, Inc.. The 510(k) number is K230352.

When did Tornier Humeral Nail and Tornier Long Humeral Nail receive FDA 510(k) clearance?

Tornier Humeral Nail and Tornier Long Humeral Nail received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230352.

Who is the listed applicant for Tornier Humeral Nail and Tornier Long Humeral Nail?

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

What is the FDA product code for Tornier Humeral Nail and Tornier Long Humeral Nail?

The FDA product code for Tornier Humeral Nail and Tornier Long Humeral Nail is HSB.

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Otros registros que enlistan a Tornier, Inc. como solicitante

K260721Tornier Perform Advanced Glenoid K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K220914Tornier Perform Humeral System – Fracture K220418Tornier Perform Humeral System – Stemless K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

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Dispositivos relacionados (Código: HSB)

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Fuente oficial

Ver en la base de datos de la FDA →

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