OJB · Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | OJB |
|---|---|
| Device Name | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151360 | Inion Spinal Graft Containment System | Inion OY | Oct 6, 2015 | SESU |
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | Inion , Ltd. | Jul 11, 2008 | SESU |
| K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | Inion , Ltd. | Nov 25, 2005 | SESE |
Top Applicants
- Inion , Ltd. — 2 clearances
- Inion OY — 1 clearance
