Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
OJM · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3060
Classification
FDA Product Code
OJM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3060
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.