Product code NVR— Unknown

“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.”

FDA has cleared 6 devices under product code NVR between 2005 and 2008, filed by 4 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

• 20082 clearances
• 20073 clearances
• 20051 clearance

• Medtronic Sofamor Danek2 clearances
• Interbody Innovations, Llp2 clearances
• Life Spine1 clearance
• Biomet Spine1 clearance

• K073274 — SPINAL SPHERE SYSTEMLife Spine·2008-03-17
• K073105 — PEEK SPINAL SPHERESInterbody Innovations, Llp·2008-01-03
• K062992 — SPINAL SPHERESInterbody Innovations, Llp·2007-07-27
• K063139 — SPINAL STABILIZING SPHERE SYSTEMBiomet Spine·2007-04-04
• K060415 — MODIFICATION TO: SATELLITE SPINAL SYSTEMMedtronic Sofamor Danek·2007-01-05
• K051320 — SATELLITE SPINAL SYSTEMMedtronic Sofamor Danek·2005-09-09