Midas Rex EM200N-R
by Medtronic Powered Surgical Solutions
Midas Rex EM200N-R is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K160713 on 26 May 2016 and listed in FDA GUDID since 30 Sep 2018 (UDI-DI 00763000172855), active as of 23 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 | Number00763000172855 | Date30 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160713 | Date26 May 2016 | StatusActive |
Official records
- AccessGUDID record 00763000172855
- FDA 510(k) database K160713
Across registries
- FDA 510(k) K160713 decided 26 May 2016 Active
- FDA GUDID UDI-DI 00763000172855 listed 30 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K160713
- Listed FDA GUDID 00763000172855
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Midas Rex
- Generic name
- Surgical power tool system control unit, line-powered
- Model / reference
- EM200N-R
- Primary DI / UDI-DI
- 00763000172855
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Surgical power tool system control unit, line-powered
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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