K073274 is the FDA 510(k) clearance record for SPINAL SPHERE SYSTEM, a class III device, cleared for Life Spine on under FDA product code NVR (Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar). FDA's definition for product code NVR reads: "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...". FDA records list 123 510(k) clearances for Life Spine, from to . As of , FDA records show no recalls naming K073274.
Clearance record
Decision date
Received
(117 days to decision)
Product code
NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Device class
Class III
Review panel
Unknown
Applicant
Life Spine 2401 W. Hassell Rd., Hoffman Estates IL
