FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)— 510(k) K003212
Substantially EquivalentDisco-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.. Device class: 2.
Clearance details
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Product code
- Code JDS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, D.C., DC, US
Recent devices under product code JDS
view allMore clearances from Disco-O-Tech Medical Technologies, Ltd.
view all- K032588 — MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
- K031401 — FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
- K023437 — FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
- K021324 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
- K012967 — MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
Adverse events under product code JDS
product code JDS- Injury
- 1,776
- Malfunction
- 1,509
- Total
- 3,285
Source: openFDA MAUDE database, through . 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.