OJM

Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh

Product code
OJM
Device name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
Device class
Class 2
21 CFR
21 CFR 888.3060
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OJM
Classification and pathway per current FDA publications. Data from openFDA (CC0).