EMPOWR Porous Knee System
K-Number: K171991 · 2017-10-04
ApplicantEncore Medical L.P.
Decision Date2017-10-04
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPOWR Porous Knee System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2017-10-04 under approval number K171991. 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 Knee System?
EMPOWR Porous Knee System is a medical device that received FDA 510(k) clearance on 2017-10-04. It is manufactured by Encore Medical L.P.. The 510(k) number is K171991.
When was EMPOWR Porous Knee System approved by the FDA?
EMPOWR Porous Knee System received FDA 510(k) clearance on 2017-10-04, under approval number K171991.
What company makes EMPOWR Porous Knee System?
EMPOWR Porous Knee System is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR Porous Knee System?
The FDA product code for EMPOWR Porous Knee System is MBH.
Related Clinical Trials
Other Devices by Encore Medical L.P.
Related Devices (Code: MBH)
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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.