DeviceClearance

Product code OJB— Orthopedic

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

Classification name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OJB under 21 CFR 888.3060, via openFDA

Market context for product code OJB

FDA has cleared 3 devices under product code OJB between 2005 and 2015, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OJB

Recent clearances under product code OJB

Data sourced from openFDA. This site is unofficial and independent of the FDA.