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FDA 510(k)

Empowr CR Knee Tibial Insert

K-Number: K170573 · 2017-05-31

Decision Date2017-05-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Empowr CR Knee Tibial Insert is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2017-05-31 under approval number K170573. 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 CR Knee Tibial Insert?

Empowr CR Knee Tibial Insert is a medical device that received FDA 510(k) clearance on 2017-05-31. It is manufactured by Encore Medical L.P.. The 510(k) number is K170573.

When was Empowr CR Knee Tibial Insert approved by the FDA?

Empowr CR Knee Tibial Insert received FDA 510(k) clearance on 2017-05-31, under approval number K170573.

What company makes Empowr CR Knee Tibial Insert?

Empowr CR Knee Tibial Insert is manufactured by Encore Medical L.P..

What is the FDA product code for Empowr CR Knee Tibial Insert?

The FDA product code for Empowr CR Knee Tibial Insert is JWH.

Other Devices by Encore Medical L.P.

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Related Devices (Code: JWH)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.