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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 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 2016-11-09 under 510(k) 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. The listed applicant is Encore Medical L.P.. The 510(k) number is K161610.

When did EXPRT Revision Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for EXPRT Revision Hip System?

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 EXPRT Revision Hip System?

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

Other records listing Encore Medical L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252567AltiVate Reverse® ADLC GlenosphereK252974EMPOWR KneeK251833EMPOWR Acetabular® Liner ExtensionK252141AltiVate Reverse® GlenoidK251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

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Related Devices (Code: KWZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UCK162641Smith & 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.

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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