MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
FDA 510(k) clearance K013449 · decided 2001-12-19
Clearance details
- K-number
- K013449
- Device name
- MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-17
- Decision date
- 2001-12-19
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzelia, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.