OJB · Class II · 21 CFR 888.3060

FDA Product Code OJB: Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

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.

Leading manufacturers include Inion , Ltd. and Inion OY.

3
Total
3
Cleared
219d
Avg days
2005
Since

FDA 510(k) Cleared Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate Devices (Product Code OJB)

3 devices
1–3 of 3
Cleared Oct 06, 2015
Inion Spinal Graft Containment System
K151360
Inion OY
Orthopedic · 139d
Cleared Jul 11, 2008
INION SPINAL GRAFT CONTAINMENT SYSTEM
K071810
Inion , Ltd.
Orthopedic · 375d
Cleared Nov 25, 2005
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
K051821
Inion , Ltd.
Orthopedic · 143d

About Product Code OJB - Regulatory Context