FDA 510(k)

Freedom Ultra-Congruent CR Tibial Liner

Número K: K182574 · 2019-01-22

Data da decisão2019-01-22

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Freedom Ultra-Congruent CR Tibial Liner is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K182574. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Freedom Ultra-Congruent CR Tibial Liner?

Freedom Ultra-Congruent CR Tibial Liner is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K182574.

When did Freedom Ultra-Congruent CR Tibial Liner receive FDA 510(k) clearance?

Freedom Ultra-Congruent CR Tibial Liner received FDA 510(k) clearance on 2019-01-22, under 510(k) number K182574.

Who is the listed applicant for Freedom Ultra-Congruent CR Tibial Liner?

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

What is the FDA product code for Freedom Ultra-Congruent CR Tibial Liner?

The FDA product code for Freedom Ultra-Congruent CR Tibial Liner is JWH.

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Outros registros que listam Maxx Orthopedics, Inc. como candidato(a)

K261563Freedom Total Knee System (E-Poly Tibial Liners)K261609Freedom Partial Knee System K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)K253314Freedom Infinia™ Total Knee System K253144Freedom® Total Knee System – Titan PCK Components

Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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