Midas Rex® BM110
by Medtronic Powered Surgical Solutions
Midas Rex® BM110 is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K012453 on 22 Oct 2001 and listed in FDA GUDID since 11 Jun 2018 (UDI-DI 00643169999152), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169999152 | Date11 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012453 | Date22 Oct 2001 | StatusActive |
Official records
- AccessGUDID record 00643169999152
- FDA 510(k) database K012453
Across registries
- FDA 510(k) K012453 decided 22 Oct 2001 Active
- FDA GUDID UDI-DI 00643169999152 listed 11 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K012453
- Listed FDA GUDID 00643169999152
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Midas Rex®
- Generic name
- Manual bone mill
- Model / reference
- BM110
- Primary DI / UDI-DI
- 00643169999152
- 510(k) Number
- FDA product code
- HBC
- GMDN term
- Manual bone mill
- Device class
- Class II
- Regulation number
- 882.4360
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Manual bone mill.