MODIFICATION TO: SATELLITE SPINAL SYSTEM
FDA 510(k) clearance K060415 · decided 2007-01-05
Clearance details
- K-number
- K060415
- Device name
- MODIFICATION TO: SATELLITE SPINAL SYSTEM
- Applicant
- Medtronic Sofamor Danek
- Decision
- Unknown
- Date received
- 2006-02-17
- Decision date
- 2007-01-05
- Days to decision
- 322 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
+ Add to Predicate Builder ◉ Watch Medtronic Sofamor Danek
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| SATELLITE SPINAL SYSTEM (K051320) | Medtronic Sofamor Danek | 2005-09-09 |
Recalls involving this device
No recalls on record reference this clearance.