FDA 510(k)

Symmetric Total Knee System

K-Number: K203779 · 2021-06-10

Decision Date2021-06-10

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Symmetric Total Knee System is a medical device manufactured by Signal Medical Corporation. It received FDA 510(k) clearance on 2021-06-10 under approval number K203779. 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 Symmetric Total Knee System?

Symmetric Total Knee System is a medical device that received FDA 510(k) clearance on 2021-06-10. It is manufactured by Signal Medical Corporation. The 510(k) number is K203779.

When was Symmetric Total Knee System approved by the FDA?

Symmetric Total Knee System received FDA 510(k) clearance on 2021-06-10, under approval number K203779.

What company makes Symmetric Total Knee System?

Symmetric Total Knee System is manufactured by Signal Medical Corporation.

What is the FDA product code for Symmetric Total Knee System?

The FDA product code for Symmetric Total Knee System is MBH.

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Related PubMed Literature

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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 K171365Arthrex Knee SystemsArthrex, Inc.

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.