FDA 510(k)

Unity Total Knee System, Unity Knee Cementless CR Femur

Número K: K261275 · 2026-09-17

Data da decisão2026-09-17

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Unity Total Knee System, Unity Knee Cementless CR Femur is the device name listed in this FDA 510(k) record. The listed applicant is Corin, Ltd.. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K261275. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Unity Total Knee System, Unity Knee Cementless CR Femur?

Unity Total Knee System, Unity Knee Cementless CR Femur is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Corin, Ltd.. The 510(k) number is K261275.

When did Unity Total Knee System, Unity Knee Cementless CR Femur receive FDA 510(k) clearance?

Unity Total Knee System, Unity Knee Cementless CR Femur received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261275.

Quem é o solicitante listado para o Unity Total Knee System, Unity Knee Cementless CR Femur?

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

What is the FDA product code for Unity Total Knee System, Unity Knee Cementless CR Femur?

The FDA product code for Unity Total Knee System, Unity Knee Cementless CR Femur is MBH.

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Outros registros que listam Corin, Ltd. como candidato(a)

K261576Icona Hip Stem K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads K200888OMNIBotics Knee System

Dispositivos Relacionados (Código: MBH)

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.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fonte oficial

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