FDA 510(k)

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

N.º K: K172634 · 2017-11-16

SolicitanteHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Fecha de decisión2017-11-16

Código de productoMBH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172634. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K172634.

When did Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components receive FDA 510(k) clearance?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172634.

Who is the listed applicant for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

The FDA product code for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is MBH.

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Otros registros que enlistan a Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics como solicitante

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Dispositivos relacionados (Código: MBH)

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Fuente oficial

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