Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
FDA product code OJB · Class II (moderate risk) · 21 CFR 888.3060 · Orthopedic
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.
3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151360 | Inion Spinal Graft Containment SystemOJB · Traditional | Inion OY | 10/06/2015SESU |
| K071810 | Inion Spinal Graft Containment SystemOJB · Traditional | Inion , Ltd. | 07/11/2008SESU |
| K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion SystemOJB · Traditional | Inion , Ltd. | 11/25/2005SE |