Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2021-03-30 under approval 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. It is manufactured by Encore Medical L.P.. The 510(k) number is K210308.

When was EMPOWR Porous Femur with HAnano SurfaceTM approved by the FDA?

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

What company makes EMPOWR Porous Femur with HAnano SurfaceTM?

EMPOWR Porous Femur with HAnano SurfaceTM is manufactured by Encore Medical L.P..

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 Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip 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

View all 31 devices →

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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.

↑