EXTREMITY MEDICAL IP FUSION SYSTEM— 510(k) K130120

Substantially Equivalent

Extremity Medical, LLC

FDA 510(k) clearance K130120 for EXTREMITY MEDICAL IP FUSION SYSTEM, Substantially Equivalent on 2013-04-11. Applicant: Extremity Medical, LLC.

Clearance details

Applicant: Extremity Medical, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2013-01-17
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
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.