FDA Registration
Active
🇺🇸 United States
Stealth Autoguide
Reg #: 1625507
·
FEI: 1625507
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Registration Number
- 1625507
- FEI Number
- 1625507
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4620 NORTH BEACH ST.
- City
- FORT WORTH
- State
- TX
- ZIP
- 76137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191597
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-12-05 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2019-12-05 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-12-05 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2019-12-05 |
Proprietary Names
Stealth Autoguide
Midas Rex Legend Depth Stop System
Establishment Types
Manufacture Medical Device