OJB — Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate Class II

FDA Device Classification

Classification Details

Product Code: OJB
Device Class: Class II
Regulation Number: 888.3060
Submission Type
Review Panel: OR
Medical Specialty: Orthopedic
Implant: Yes

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K151360	inion	Inion Spinal Graft Containment System	October 6, 2015
K071810	inion	INION SPINAL GRAFT CONTAINMENT SYSTEM	July 11, 2008
K051821	inion	INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM	November 25, 2005