510(k) K012453— SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)

Substantially Equivalent

Sodemsystems

Clearance details

Applicant: Sodemsystems
Product code: Code HBC
Advisory panel: Neurology
Date received: 2001-08-01
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.