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Intervertebral Fusion Device With Integrated Fixation, Lumbar

FDA product code OVD · 179 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3080
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-09-18 – 2026-09-11

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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