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FDA 510(k)

EXPRT Revision Hip System

K-Number: K161610 · 2016-11-09

ApplicantEncore Medical L.P.
Decision Date2016-11-09
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPRT Revision Hip System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2016-11-09 under approval number K161610. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPRT Revision Hip System?

EXPRT Revision Hip System is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Encore Medical L.P.. The 510(k) number is K161610.

When was EXPRT Revision Hip System approved by the FDA?

EXPRT Revision Hip System received FDA 510(k) clearance on 2016-11-09, under approval number K161610.

What company makes EXPRT Revision Hip System?

EXPRT Revision Hip System is manufactured by Encore Medical L.P..

What is the FDA product code for EXPRT Revision Hip System?

The FDA product code for EXPRT Revision Hip System is KWZ.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

View all 31 devices →

Related Devices (Code: KWZ)

K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc. K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P. K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC K241461Mpact Constrained LinerMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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