LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60— 510(k) K050407

Substantially Equivalent

Sciences For Bio Materials

FDA 510(k) clearance K050407 for LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60, Substantially Equivalent on 2005-11-04. Applicant: Sciences For Bio Materials.

Clearance details

Applicant: Sciences For Bio Materials
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2005-02-17
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
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.