FDA 510(k)

Arthrex Knee Systems

K-Number: K171365 · 2017-11-07

Decision Date2017-11-07

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex Knee Systems is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-11-07 under approval number K171365. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Knee Systems?

Arthrex Knee Systems is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by Arthrex, Inc.. The 510(k) number is K171365.

When was Arthrex Knee Systems approved by the FDA?

Arthrex Knee Systems received FDA 510(k) clearance on 2017-11-07, under approval number K171365.

What company makes Arthrex Knee Systems?

Arthrex Knee Systems is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Knee Systems?

The FDA product code for Arthrex Knee Systems is MBH.

Other Devices by Arthrex, Inc.

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171991EMPOWR Porous Knee SystemEncore Medical L.P.

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.