Home / 510(k) Clearances / K073105

510(k) K073105

PEEK SPINAL SPHERES by Interbody Innovations, Llp — Product Code NVR

Clearance Details

Decision
SESU ()
Decision Date
January 3, 2008
Date Received
November 2, 2007
Clearance Type
Special
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.

Other clearances by Interbody Innovations, Llp

  • K081614 — ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGE (September 5, 2008)
  • K062992 — SPINAL SPHERES (July 27, 2007)
  • K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR (December 6, 2005)

Other clearances for product code NVR

  • K073274 — SPINAL SPHERE SYSTEM (March 17, 2008)
  • K062992 — SPINAL SPHERES (July 27, 2007)
  • K063139 — SPINAL STABILIZING SPHERE SYSTEM (April 4, 2007)
  • K060415 — MODIFICATION TO: SATELLITE SPINAL SYSTEM (January 5, 2007)
  • K051320 — SATELLITE SPINAL SYSTEM (September 9, 2005)