IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER— 510(k) K121349

Name: FDA 510(k) clearance K121349
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Substantially Equivalent

Extremity Medical, LLC

FDA 510(k) clearance K121349 for IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER, Substantially Equivalent on 2012-07-18. Applicant: Extremity Medical, LLC. Device class: 2.

Clearance details

Applicant: Extremity Medical, LLC
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2012-05-04
Decision date: 2012-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.