FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)— 510(k) K003212

Substantially Equivalent

Disco-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K003212 for FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL), Substantially Equivalent on 2000-12-28. Applicant: Disco-O-Tech Medical Technologies, Ltd..

Clearance details

Applicant: Disco-O-Tech Medical Technologies, Ltd.
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 2000-10-13
Decision date: 2000-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.