TC PLATING SYSTEM— 510(k) K094037

Name: FDA 510(k) clearance K094037
Creator: U.S. Food and Drug Administration
Published: 2010-03-10

Substantially Equivalent

Ortho-Pro, LLC

FDA 510(k) clearance K094037 for TC PLATING SYSTEM, Substantially Equivalent on 2010-03-10. Applicant: Ortho-Pro, LLC. Device class: 2.

Clearance details

Applicant: Ortho-Pro, LLC
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2009-12-30
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.