EMPOWR VVC TIBIAL INSERT
K-Number: K180930 · 2018-07-09
ApplicantEncore Medical L.P.
Decision Date2018-07-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPOWR VVC TIBIAL INSERT is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2018-07-09 under approval number K180930. 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 VVC TIBIAL INSERT?
EMPOWR VVC TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2018-07-09. It is manufactured by Encore Medical L.P.. The 510(k) number is K180930.
When was EMPOWR VVC TIBIAL INSERT approved by the FDA?
EMPOWR VVC TIBIAL INSERT received FDA 510(k) clearance on 2018-07-09, under approval number K180930.
What company makes EMPOWR VVC TIBIAL INSERT?
EMPOWR VVC TIBIAL INSERT is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR VVC TIBIAL INSERT?
The FDA product code for EMPOWR VVC TIBIAL INSERT 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.