FDA product code LBM: Porous Polyethylene Ossicular Replacement
LBM is the FDA product code for porous polyethylene ossicular replacement. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under LBM. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Porous Polyethylene Ossicular Replacement |
| Device class | Class II |
| Regulation | 21 CFR 874.3450 |
| 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 LBM clearance
Top LBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 2 | 1982-12-03 |
Most recent LBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823441 | Treace Medical, Inc. | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | 1982-12-03 | 17 |
| K823442 | Treace Medical, Inc. | FISCH MODIFIED TOTAL OSSICULAR PROSTHES | 1982-12-03 | 17 |
Recalls for LBM devices
openFDA lists no recalls for product code LBM.
Frequently asked questions
What is FDA product code LBM?
LBM is the FDA product code for porous polyethylene ossicular replacement. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel.
What device class is LBM?
Class II, regulation 21 CFR 874.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBM?
Across 2 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most LBM clearances?
Treace Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LBM
- Run a recall and safety report across every LBM manufacturer
- Watch product code LBM 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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