LBN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3495
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TOTAL (K822367) | Treace Medical, Inc. | 1982-09-07 |
Track LBN automatically
Every clearance here is in the API, with alerts when new ones post.