FDA 510(k)

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

N.º K: K241878 · 2024-12-06

SolicitanteStryker Corporation (Tornier, Inc.)

Fecha de decisión2024-12-06

Código de productoKWS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241878. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241878.

When did Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241878.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

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

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is KWS.

Ensayos clínicos relacionados

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Otros registros que enlistan a Stryker Corporation (Tornier, Inc.) como solicitante

K260102Tornier Perform Reversa Glénoide y Tornier Perform Reversa Glénoide Aumentada del Hombro Sistema K241609Tornier Humeral Reconstruction System (Tornier HRS)

Dispositivos relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Hombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótesis Humeral Meta AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)

Fuente oficial

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