MODIFICATION TO: LIGAFIX INTERFERENCE SCREW— 510(k) K070507

Substantially Equivalent

Science For Biomaterials

FDA 510(k) clearance K070507 for MODIFICATION TO: LIGAFIX INTERFERENCE SCREW, Substantially Equivalent on 2007-03-29. Applicant: Science For Biomaterials.

Clearance details

Applicant: Science For Biomaterials
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2007-02-21
Decision date: 2007-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Lourdes, FR

Download summary PDF View on FDA.gov ↗

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.