SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020— 510(k) K042295

Substantially Equivalent

Linvatec Biomaterials, Ltd.

FDA 510(k) clearance K042295 for SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020, Substantially Equivalent on 2004-09-16. Applicant: Linvatec Biomaterials, Ltd..

Clearance details

Applicant: Linvatec Biomaterials, Ltd.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2004-08-24
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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.