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510(k) K062992

SPINAL SPHERES by Interbody Innovations, Llp — Product Code NVR

Clearance Details

Decision
SESU ()
Decision Date
July 27, 2007
Date Received
October 2, 2006
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.

Other clearances by Interbody Innovations, Llp

  • K081614 — ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGE (September 5, 2008)
  • K073105 — PEEK SPINAL SPHERES (January 3, 2008)
  • K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR (December 6, 2005)

Other clearances for product code NVR

  • K073274 — SPINAL SPHERE SYSTEM (March 17, 2008)
  • K073105 — PEEK SPINAL SPHERES (January 3, 2008)
  • K063139 — SPINAL STABILIZING SPHERE SYSTEM (April 4, 2007)
  • K060415 — MODIFICATION TO: SATELLITE SPINAL SYSTEM (January 5, 2007)
  • K051320 — SATELLITE SPINAL SYSTEM (September 9, 2005)