510(k) K051320
- Device
- SATELLITE SPINAL SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K051320
- Product code
- NVR
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2005-09-09
- Date received
- 2005-05-20
- Regulation
- 510(k) Premarket Notification
- Classification name
- Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD W TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 1526534
- 1824199
- 3018094310
- 1030489
Source Documents#
Other 510(k) Records For Product Code NVR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073274 | SPINAL SPHERE SYSTEM | Life Spine | 2008-03-17 |
| K073105 | PEEK SPINAL SPHERES | Interbody Innovations, Llp | 2008-01-03 |
| K062992 | SPINAL SPHERES | Interbody Innovations, Llp | 2007-07-27 |
| K063139 | SPINAL STABILIZING SPHERE SYSTEM | Biomet Spine | 2007-04-04 |
| K060415 | MODIFICATION TO: SATELLITE SPINAL SYSTEM | Medtronic Sofamor Danek | 2007-01-05 |
Legacy Summary#
summary
FDA Review#
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