LYS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bone Mill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2020: 66 · 2021: 173 · 2022: 201 · 2023: 386 · 2024: 305 · 2025: 26
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 |
|---|---|---|
| TRACER BONE MILL (K883183) | De Medica Mfg., Inc. | 1988-10-12 |
| ORTHOBLEND POWERED BONE MILL (K860356) | Zimmer, Inc. | 1986-07-08 |
| OSTEOMILL BONE GRINDER (K861164) | Biodynamic Technologies, Inc. | 1986-05-02 |
| AESCULAP BONE MILL (K860016) | Aesculap Instruments Corp. | 1986-03-19 |
Track LYS automatically
Every clearance here is in the API, with alerts when new ones post.