MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)— 510(k) K032588
Substantially EquivalentDisco-O-Tech Medical Technologies, Ltd.
FDA 510(k) clearance K032588 for MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM), Substantially Equivalent on 2003-09-12. Applicant: Disco-O-Tech Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Herzlia, IL
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- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Disco-O-Tech Medical Technologies, Ltd.
view all- 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
- K003212 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.