FDA 510(k)

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

Número K: K230169 · 2023-04-06

RequerenteEncore Medical, L.P Dba Enovis

Data da decisão2023-04-06

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, L.P Dba Enovis. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K230169. 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 EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Encore Medical, L.P Dba Enovis. The 510(k) number is K230169.

When did EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert receive FDA 510(k) clearance?

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert received FDA 510(k) clearance on 2023-04-06, under 510(k) number K230169.

Who is the listed applicant for EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

The FDA 510(k) record lists Encore Medical, L.P Dba Enovis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

The FDA product code for EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is JWH.

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Outros registros que listam Encore Medical, L.P Dba Enovis como candidato(a)

K240324EMPOWR Revision Symmetric Knee Cones K230441EMPOWR Stem Extender, 50mm

Dispositivos Relacionados (Código: JWH)

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Fonte oficial

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