FDA 510(k)

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

K-Nummer: K251241 · 2025-07-02

Entscheidungsdatum2025-07-02

ProduktcodeJWH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251241. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Encore Medical L.P.. The 510(k) number is K251241.

When did EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) receive FDA 510(k) clearance?

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251241.

Who is the listed applicant for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

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

What is the FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

The FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is JWH.

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Weitere Einträge mit Encore Medical L.P. als Antragsteller

K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141AltiVate Reverse® Glenoid K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

Alle 31 Geräte anzeigen →

Verwandte Geräte (Code: 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 Revision KniegelenkssystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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