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FDA 510(k)

EMPOWR Partial Knee

K-Number: K191325 · 2019-07-16

ApplicantEncore Medical L.P.
Decision Date2019-07-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR Partial Knee 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 2019-07-16 under 510(k) number K191325. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR Partial Knee?

EMPOWR Partial Knee is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Encore Medical L.P.. The 510(k) number is K191325.

When did EMPOWR Partial Knee receive FDA 510(k) clearance?

EMPOWR Partial Knee received FDA 510(k) clearance on 2019-07-16, under 510(k) number K191325.

Who is the listed applicant for EMPOWR Partial Knee?

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 Partial Knee?

The FDA product code for EMPOWR Partial Knee is HSX.

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: HSX)

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.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

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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