FDA product code OCJ: Spinal Channeling Instrument, Vertebroplasty
OCJ is the FDA product code for spinal channeling instrument, vertebroplasty. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under OCJ. The average 510(k) review took 160 days (median 160). FDA has posted 2 recalls for OCJ devices.
Definition
Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OCJ clearance
Top OCJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Benvenue Medical, Inc. | 1 | 2007-07-10 |
Most recent OCJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070293 | Benvenue Medical, Inc. | BENVENUE VCF OSTEO COIL SYSTEM | 2007-07-10 | 160 |
Recalls for OCJ devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-22.
Frequently asked questions
What is FDA product code OCJ?
OCJ is the FDA product code for spinal channeling instrument, vertebroplasty. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is OCJ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OCJ?
Across 1 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most OCJ clearances?
Benvenue Medical, Inc. (1).
Have OCJ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2011-03-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OCJ
- Run a recall and safety report across every OCJ manufacturer
- Watch product code OCJ 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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