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

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.

Clearance details

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

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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.