FDA Registration
Active
🇺🇸 United States
MEDTRONIC POWERED SURGICAL SOLUTIONS
Reg #: 1625507
·
FEI: 1625507
·
Expires 2026
Products
15
Proprietary Names
37
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Registration Number
- 1625507
- FEI Number
- 1625507
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4620 NORTH BEACH ST.
- City
- FORT WORTH
- State
- TX
- ZIP
- 76137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183515
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 |
|---|---|---|---|---|---|
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2019-05-22 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-05-22 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-05-22 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2019-05-22 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2006-09-06 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2017-05-05 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Parathyroid Autofluorescence Detection Device | QDF | Class 2 | General, Plastic Surgery | No | 2020-03-27 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-09-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2017-05-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-05-30 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-05-24 |
Proprietary Names
MR8 Drill System
Midas Rex MR8 ClearView Tools
Bone Mill
Midas Rex Legend Clearview Tools
Midas Rex Legend Attachments
Midas Rex Legend Curved Burs
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill Systems incorporating various Pneumatic Handpieces
Midas Rex Legend Surgical Dissecting Tools
PTEYE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE
Stealth-Midas System
Medtronic Electric Handpiece
Midas Rex Legend Pneumatic System
Midas Rex Classic system
IPC - Integrated Power Console Drill System
Clearview Surgical Dissecting Tools
Midas Rex Legend Drill System
Stealth-Midas MR8 System
Irrigation Tubing Sets
Saw Blades
Saw Handpieces (Reciprocating, Oscillating, Sagittal)
Microsaw Rasps
Integrated Power Console
Foot Control
Cooling Tubing Sets
Cranial/Ortho/Neuro Elec Drill Sys
Triton Electric High Torque Handpiece And Accessories
MR7 System
Midas Rex MR8 Pneumatic and Electric Drill System
Legend Pneumatic Cable
Midas Rex Curved Burs
Midas Rex MR8
Triton Pneumatic Drill System
Stealth Autoguide
Midas Rex Legend Depth Stop System
ENT Drill & Handpiece, elec & pneu
STEALTH AXIS
Midas Rex Attachments and Dissecting Tools
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility