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FDA 510(k)

EMPOWR Porous Femur with HAnano SurfaceTM

K-Number: K210308 · 2021-03-30

ApplicantEncore Medical L.P.
Decision Date2021-03-30
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR Porous Femur with HAnano SurfaceTM 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 2021-03-30 under 510(k) number K210308. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR Porous Femur with HAnano SurfaceTM?

EMPOWR Porous Femur with HAnano SurfaceTM is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Encore Medical L.P.. The 510(k) number is K210308.

When did EMPOWR Porous Femur with HAnano SurfaceTM receive FDA 510(k) clearance?

EMPOWR Porous Femur with HAnano SurfaceTM received FDA 510(k) clearance on 2021-03-30, under 510(k) number K210308.

Who is the listed applicant for EMPOWR Porous Femur with HAnano SurfaceTM?

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 Porous Femur with HAnano SurfaceTM?

The FDA product code for EMPOWR Porous Femur with HAnano SurfaceTM is MBH.

Other records listing Encore Medical L.P. as applicant

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Related Devices (Code: MBH)

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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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