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FDA 510(k)

DePuy ATTUNE™ Total Knee System

K-Number: K201347 · 2020-06-18

Decision Date2020-06-18
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy ATTUNE™ Total Knee System is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-06-18 under approval number K201347. The device is classified under product code OIY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy ATTUNE™ Total Knee System?

DePuy ATTUNE™ Total Knee System is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K201347.

When was DePuy ATTUNE™ Total Knee System approved by the FDA?

DePuy ATTUNE™ Total Knee System received FDA 510(k) clearance on 2020-06-18, under approval number K201347.

What company makes DePuy ATTUNE™ Total Knee System?

DePuy ATTUNE™ Total Knee System is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for DePuy ATTUNE™ Total Knee System?

The FDA product code for DePuy ATTUNE™ Total Knee System is OIY.

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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.