FDA 510(k)
FDA class 3
Unknown
🇺🇸 United States
MODIFICATION TO: SATELLITE SPINAL SYSTEM
K Number: K060415
·
Decision Jan 5, 2007
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
154
Review Days
322
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Basic Information
- Device Name
- MODIFICATION TO: SATELLITE SPINAL SYSTEM
- K Number
- K060415
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek
- Date Received
- February 17, 2006
- Decision Date
- January 5, 2007
- Product Code
- NVR
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NVR), ordered by most recent decision date.
SPINAL SPHERE SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
PEEK SPINAL SPHERES
FDA 510(k)
FDA Class 3
·Unknown
SPINAL SPHERES
FDA 510(k)
FDA Class 3
·Unknown
SPINAL STABILIZING SPHERE SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
SATELLITE SPINAL SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
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