Product code NVR ยท Class 3
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
0510(k)s in 12 months (6 all time)
0recalls in 12 months (17 all time)
1recalls that name a 510(k)
Top companies in NVR
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 2 | 17 |
| Interbody Innovations, Llp | 2 | 0 |
| Biomet Spine | 1 | 0 |
| Life Spine | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000216, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000215, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000214, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000213, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000211, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 800021, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000215, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000213, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000212, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000210, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000209, Manufactured at: Warsaw, Indiana, USA Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Spinal and Biologics Business, Memphis, TN (this guide was originally a portion of the Satellite Spin Terminated |
NVR | None listed |
| Dec 22, 2007 | Medtronic Sofamor Danek USA Inc Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132 Terminated |
NVR | K051320 |
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