510(k) K073274
K073274 is an FDA 510(k) premarket notification submitted by Life Spine for the device "SPINAL SPHERE SYSTEM". The FDA issued a decision of SESU on March 17, 2008. The device falls under product code NVR (Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar), a Class III device. Life Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- March 17, 2008
- Date Received
- November 21, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
- Device Class
- Class III
- Regulation Number
- Review Panel
- OR
- Submission Type
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.