MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
FDA 510(k) clearance K032588 · decided 2003-09-12
Clearance details
- K-number
- K032588
- Device name
- MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-22
- Decision date
- 2003-09-12
- Days to decision
- 21 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.