FDA product code OJB: Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
OJB is the FDA product code for resorbable spinal intervertebral body fixation orthosis - plate. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OJB, from 2 different applicants. The average 510(k) review took 219 days (median 143).
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.
Classification
| Field | Value |
|---|---|
| Device name | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OJB clearance
Top OJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inion , Ltd. | 2 | 2008-07-11 |
| Inion OY | 1 | 2015-10-06 |
Most recent OJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151360 | Inion OY | Inion Spinal Graft Containment System | 2015-10-06 | 139 |
| K071810 | Inion , Ltd. | INION SPINAL GRAFT CONTAINMENT SYSTEM | 2008-07-11 | 375 |
| K051821 | Inion , Ltd. | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | 2005-11-25 | 143 |
Recalls for OJB devices
openFDA lists no recalls for product code OJB.
Frequently asked questions
What is FDA product code OJB?
OJB is the FDA product code for resorbable spinal intervertebral body fixation orthosis - plate. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is OJB?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code OJB?
Across 3 cleared submissions the average was 219 days from receipt to decision (median 143).
Which companies have the most OJB clearances?
Inion , Ltd. (2); Inion OY (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OJB
- Run a recall and safety report across every OJB manufacturer
- Watch product code OJB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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