FDA 510(k)

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)

N.º K: K240299 · 2024-04-26

Fecha de decisión2024-04-26

Código de productoMBH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240299. 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 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K240299.

When did Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) receive FDA 510(k) clearance?

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240299.

Who is the listed applicant for Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

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

What is the FDA product code for Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

The FDA product code for Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is MBH.

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Otros registros que enlistan a Zimmer, Inc. como solicitante

K262955OsseoFit Stemless Shoulder System K260831Z1 Hip System K261683Augment Off-Axis Instrument System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Dispositivos relacionados (Código: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Fuente oficial

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