EMPOWR Universal Tibial Baseplate
K-Number: K173723 · 2018-03-05
ApplicantEncore Medical L.P.
Decision Date2018-03-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPOWR Universal Tibial Baseplate is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2018-03-05 under approval number K173723. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EMPOWR Universal Tibial Baseplate?
EMPOWR Universal Tibial Baseplate is a medical device that received FDA 510(k) clearance on 2018-03-05. It is manufactured by Encore Medical L.P.. The 510(k) number is K173723.
When was EMPOWR Universal Tibial Baseplate approved by the FDA?
EMPOWR Universal Tibial Baseplate received FDA 510(k) clearance on 2018-03-05, under approval number K173723.
What company makes EMPOWR Universal Tibial Baseplate?
EMPOWR Universal Tibial Baseplate is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR Universal Tibial Baseplate?
The FDA product code for EMPOWR Universal Tibial Baseplate is JWH.
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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.