FDA Registration
Active
🇺🇸 United States
IntelliSense Drill
Reg #: 3011569539
·
FEI: 3011569539
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
- Registration Number
- 3011569539
- FEI Number
- 3011569539
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 234 E. 1st Street, Ste 242
- City
- Casper
- State
- WY
- ZIP
- 82601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143191
Owner / Operator
- Firm Name
- McGinley Orthopaedic Innovations, INC
- Operator Number
- 10048881
- Address
- 234 E 1st Street, Suite 242
- City
- Casper
- State
- WY
- Postal Code
- 82601
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2015-03-16 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-03-16 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2015-03-16 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2015-03-16 |
Proprietary Names
IntelliSense Drill
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility