NVR — Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar Class III

FDA Device Classification

Classification Details

Product Code
NVR
Device Class
Class III
Regulation Number
Submission Type
Review Panel
OR
Medical Specialty
Unknown
Implant
Yes

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K073274life spineSPINAL SPHERE SYSTEMMarch 17, 2008
K073105interbody innovationsPEEK SPINAL SPHERESJanuary 3, 2008
K062992interbody innovationsSPINAL SPHERESJuly 27, 2007
K063139biomet spineSPINAL STABILIZING SPHERE SYSTEMApril 4, 2007
K060415medtronic sofamor danekMODIFICATION TO: SATELLITE SPINAL SYSTEMJanuary 5, 2007
K051320medtronic sofamor danekSATELLITE SPINAL SYSTEMSeptember 9, 2005