K051320 is the FDA 510(k) clearance record for SATELLITE SPINAL SYSTEM, a class III device, cleared for Medtronic Sofamor Danek 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 253 510(k) clearances for Medtronic Sofamor Danek, from to . As of , FDA records show 2 recalls naming K051320.
Clearance record
Decision date
Received
(112 days to decision)
Product code
NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
