510(k) K060415

Clearance Details

Decision

SESU ()

Decision Date

January 5, 2007

Date Received

February 17, 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.