FDA 510(k)

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)

N.º K: K252788 · 2026-01-08

Fecha de decisión2026-01-08

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K252788. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Tornier, Inc.. The 510(k) number is K252788.

When did Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) receive FDA 510(k) clearance?

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) received FDA 510(k) clearance on 2026-01-08, under 510(k) number K252788.

Who is the listed applicant for Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

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 Perform™ Reversed Monopost Glenoid (Perform Mono)?

The FDA product code for Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is PHX.

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Otros registros que enlistan a Tornier, Inc. como solicitante

K260721Tornier Perform Advanced Glenoid K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral Nail 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: PHX)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.