SATELLITE SPINAL SYSTEM
FDA 510(k) clearance K051320 · decided 2005-09-09
Clearance details
- K-number
- K051320
- Device name
- SATELLITE SPINAL SYSTEM
- Applicant
- Medtronic Sofamor Danek
- Decision
- Unknown
- Date received
- 2005-05-20
- Decision date
- 2005-09-09
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- NVR
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Memphis, TN, 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 |
| SPINAL STABILIZING SPHERE SYSTEM (K063139) | Biomet Spine | 2007-04-04 |
| MODIFICATION TO: SATELLITE SPINAL SYSTEM (K060415) | Medtronic Sofamor Danek | 2007-01-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binde recall (Z-0192-2008) | Medtronic Sofamor Danek USA Inc | 2007-12-22 |
| 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device recall (Z-1088-06) | Medtronic Sofamor Danek USA Inc | 2006-06-08 |