OJB

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Product code

OJB

Device name

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Device class

Class 2

21 CFR

21 CFR 888.3060

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

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).