FDA product code MBJ: Fastener, Fixation, Biodegradable, Hard Tissue
MBJ is the FDA product code for fastener, fixation, biodegradable, hard tissue. It is a Class III device, reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under MBJ. The average 510(k) review took 483 days (median 483).
Classification
| Field | Value |
|---|---|
| Device name | Fastener, Fixation, Biodegradable, Hard Tissue |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Compare with all 510(k) review times · Search every MBJ clearance
Top MBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kirschner Medical Corp. | 1 | 1993-05-12 |
Most recent MBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920188 | Kirschner Medical Corp. | THREADED PINS | 1993-05-12 | 483 |
Recalls for MBJ devices
openFDA lists no recalls for product code MBJ.
Frequently asked questions
What is FDA product code MBJ?
MBJ is the FDA product code for fastener, fixation, biodegradable, hard tissue. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MBJ?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code MBJ?
Across 1 cleared submissions the average was 483 days from receipt to decision (median 483).
Which companies have the most MBJ clearances?
Kirschner Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MBJ
- Run a recall and safety report across every MBJ manufacturer
- Watch product code MBJ 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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