Stealth Midas™ EM200N
by Medtronic Powered Surgical Solutions 2 variants
Stealth Midas™ EM200N 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 10 Sep 2016 (UDI-DI 00643169595163), 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 | Number00643169595163 | Date10 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160713 | Date26 May 2016 | StatusActive |
Official records
- AccessGUDID record 00643169595163
- FDA 510(k) database K160713
Across registries
- FDA 510(k) K160713 decided 26 May 2016 Active
- FDA GUDID UDI-DI 00643169595163 listed 10 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K160713
- Listed FDA GUDID 00643169595163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stealth Midas™
- Generic name
- Bone/joint surgical power tool motor, electric
- Model / reference
- EM200N
- Primary DI / UDI-DI
- 00643169595163
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Bone/joint surgical power tool motor, electric
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Bone/joint surgical power tool motor, electric.