FDA product code LBN: Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
LBN is the FDA product code for replacement, total ossicular, prosthesis, porous, polyethylene. It is a Class II device, regulated under 21 CFR 874.3495 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under LBN. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene |
| Device class | Class II |
| Regulation | 21 CFR 874.3495 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LBN clearance
Top LBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 1 | 1982-09-07 |
Most recent LBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822367 | Treace Medical, Inc. | TOTAL | 1982-09-07 | 32 |
Recalls for LBN devices
openFDA lists no recalls for product code LBN.
Frequently asked questions
What is FDA product code LBN?
LBN is the FDA product code for replacement, total ossicular, prosthesis, porous, polyethylene. It is a Class II device, regulated under 21 CFR 874.3495 and reviewed by the Ear, Nose and Throat panel.
What device class is LBN?
Class II, regulation 21 CFR 874.3495. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBN?
Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most LBN clearances?
Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBN
- Run a recall and safety report across every LBN manufacturer
- Watch product code LBN 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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