510(k) K062992
- Device
- SPINAL SPHERES
- Applicant
- INTERBODY INNOVATIONS LLP
- 510(k) number
- K062992
- Product code
- NVR
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2007-07-27
- Date received
- 2006-10-02
- 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
- J D WEBB
- Address
- 1001 Oakwood Blvd. Round Rock TX US 78681 78681
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 |
| K063139 | SPINAL STABILIZING SPHERE SYSTEM | Biomet Spine | 2007-04-04 |
| K060415 | MODIFICATION TO: SATELLITE SPINAL SYSTEM | Medtronic Sofamor Danek | 2007-01-05 |
| K051320 | SATELLITE SPINAL SYSTEM | Medtronic Sofamor Danek | 2005-09-09 |
Legacy Summary#
summary
FDA Review#
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