TITANIUM CANNULATED INTERFERENCE SCREW— 510(k) K033749

Substantially Equivalent

Advanced Biomaterials

FDA 510(k) clearance K033749 for TITANIUM CANNULATED INTERFERENCE SCREW, Substantially Equivalent on 2004-02-23. Applicant: Advanced Biomaterials.

Clearance details

Applicant: Advanced Biomaterials
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2003-12-01
Decision date: 2004-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Jeannet, 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.