FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
FDA 510(k) clearance K023437 · decided 2002-11-14
Clearance details
- K-number
- K023437
- Device name
- FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-15
- Decision date
- 2002-11-14
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzlia, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.