LBM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Porous Polyethylene Ossicular Replacement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3450
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FISCH MODIFIED TOTAL OSSICULAR PROSTHES (K823442) | Treace Medical, Inc. | 1982-12-03 |
| AUSTIN MODIFIED TOTAL OSSICULAR REPLACE (K823441) | Treace Medical, Inc. | 1982-12-03 |
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