SPINAL STABILIZING SPHERE SYSTEM
FDA 510(k) clearance K063139 · decided 2007-04-04
Clearance details
- K-number
- K063139
- Device name
- SPINAL STABILIZING SPHERE SYSTEM
- Applicant
- Biomet Spine
- Decision
- Unknown
- Date received
- 2006-10-16
- Decision date
- 2007-04-04
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- NVR
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPINAL SPHERE SYSTEM (K073274) | Life Spine | 2008-03-17 |
| PEEK SPINAL SPHERES (K073105) | Interbody Innovations, Llp | 2008-01-03 |
| SPINAL SPHERES (K062992) | Interbody Innovations, Llp | 2007-07-27 |
| MODIFICATION TO: SATELLITE SPINAL SYSTEM (K060415) | Medtronic Sofamor Danek | 2007-01-05 |
| SATELLITE SPINAL SYSTEM (K051320) | Medtronic Sofamor Danek | 2005-09-09 |
Recalls involving this device
No recalls on record reference this clearance.