FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
FDA 510(k) clearance K020279 · decided 2002-06-20
Clearance details
- K-number
- K020279
- Device name
- FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
- Applicant
- Forex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-28
- Decision date
- 2002-06-20
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- MNI
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optima Spinal System and Spinal Hook System, set screw component. recall (Z-1438-04) | U&I America | 2004-09-08 |
| 2.5mm Hex Driver recall (Z-0558-04) | U&I America | 2004-02-27 |
| 4mm Hex Driver recall (Z-0559-04) | U&I America | 2004-02-27 |
| Optima Poly Screw Driver. recall (Z-1182-03) | U&I America | 2003-08-27 |