FDA 510(k)

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

K-번호: K230169 · 2023-04-06

결정일2023-04-06

제품 코드JWH

자문 위원회OR

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Encore Medical, L.P Dba Enovis를 신청인으로 등재한 기타 기록

K240324EMPOWR Revision Symmetric Knee Cones K230441EMPOWR Stem Extender, 50mm

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