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FDA 510(k)

MyKnee PPS-Pin Positioners

K-Number: K170106 · 2017-10-20

Decision Date2017-10-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MyKnee PPS-Pin Positioners is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-10-20 under approval number K170106. 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 MyKnee PPS-Pin Positioners?

MyKnee PPS-Pin Positioners is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Medacta International S.A.. The 510(k) number is K170106.

When was MyKnee PPS-Pin Positioners approved by the FDA?

MyKnee PPS-Pin Positioners received FDA 510(k) clearance on 2017-10-20, under approval number K170106.

What company makes MyKnee PPS-Pin Positioners?

MyKnee PPS-Pin Positioners is manufactured by Medacta International S.A..

What is the FDA product code for MyKnee PPS-Pin Positioners?

The FDA product code for MyKnee PPS-Pin Positioners is JWH.

Other Devices by Medacta International S.A.

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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.