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Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA product code OVE · 144 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
2007-10-23 – 2026-09-23

Intended to stabilize cervical 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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