LYS — Bone Mill Class I
FDA product code LYS covers "Bone Mill", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYS
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No