OJB

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3060

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free