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FDA 510(k)

Symmetric Total Knee System

K-Number: K203779 · 2021-06-10

ApplicantSignal Medical Corporation
Decision Date2021-06-10
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Symmetric Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corporation. It received FDA 510(k) clearance on 2021-06-10 under 510(k) 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. The listed applicant is Signal Medical Corporation. The 510(k) number is K203779.

When did Symmetric Total Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Symmetric Total Knee System?

The FDA 510(k) record lists Signal Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

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