SYNTHES USS (10.0MM SIDE OPENING SCREWS)— 510(k) K003061

Substantially Equivalent

Synthes

FDA 510(k) clearance K003061 for SYNTHES USS (10.0MM SIDE OPENING SCREWS), Substantially Equivalent on 2000-10-30. Applicant: Synthes.

Clearance details

Applicant: Synthes
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2000-10-02
Decision date: 2000-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.