Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
The Solid-Sphere Lumbar Intervertebral Fusion Device with Bone Graft is a spinal implant intended to be inserted between vertebral bodies in the disc space from L3 to S1 to provide stabilization and promote intervertebral body fusion, used with bone graft and not intended for motion-sparing or non-fusion procedures. The device is classified per the Federal Register at 2023-06566. As an FDA Class 3 device requiring Premarket Approval (PMA), it is reviewed by the Orthopedic panel with product code NVR. The device is flagged as an implant given its permanent surgical placement in the lumbar spine.
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Basic Information
- Product Code
- NVR
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073274 | SPINAL SPHERE SYSTEM | Mar 17, 2008 | Unknown | Life Spine |
| K073105 | PEEK SPINAL SPHERES | Jan 03, 2008 | Unknown | Interbody Innovations, Llp |
| K062992 | SPINAL SPHERES | Jul 27, 2007 | Unknown | Interbody Innovations, Llp |
| K063139 | SPINAL STABILIZING SPHERE SYSTEM | Apr 04, 2007 | Unknown | Biomet Spine |
| K060415 | MODIFICATION TO: SATELLITE SPINAL SYSTEM | Jan 05, 2007 | Unknown | Medtronic Sofamor Danek |
| K051320 | SATELLITE SPINAL SYSTEM | Sep 09, 2005 | Unknown | Medtronic Sofamor Danek |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.