Symmetric Total Knee System— 510(k) K203779

Name: FDA 510(k) clearance K203779
Creator: U.S. Food and Drug Administration
Published: 2021-06-10

Substantially Equivalent

Signal Medical Corporation

FDA 510(k) clearance K203779 for Symmetric Total Knee System, Substantially Equivalent on 2021-06-10. Applicant: Signal Medical Corporation. Device class: 2.

Clearance details

Applicant: Signal Medical Corporation
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2020-12-28
Decision date: 2021-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marysville, MI, US

Download summary PDF View on FDA.gov ↗

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K080199 — SYMMETRIC TOTAL KNEE SYSTEM2008-07-03

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.