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 a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2019-07-16 under approval 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. It is manufactured by Encore Medical L.P.. The 510(k) number is K191325.
When was EMPOWR Partial Knee approved by the FDA?
EMPOWR Partial Knee received FDA 510(k) clearance on 2019-07-16, under approval number K191325.
What company makes EMPOWR Partial Knee?
EMPOWR Partial Knee is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR Partial Knee?
The FDA product code for EMPOWR Partial Knee is HSX.
Other Devices by Encore Medical L.P.
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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.