UCR SPINAL SYSTEM
FDA 510(k) clearance K043232 · decided 2004-12-21
Clearance details
- K-number
- K043232
- Device name
- UCR SPINAL SYSTEM
- Applicant
- Seaspine
- Decision
- Substantially Equivalent
- Date received
- 2004-11-22
- Decision date
- 2004-12-21
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument recall (Z-1841-2014) | SeaSpine Inc | 2014-06-20 |