FDA Registration
Active
🇺🇸 United States
Canaveral Pedicle Screw System
Reg #: 1530530
·
FEI: 3000718985
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TROY INNOVATIVE INSTRUMENTS, INC.
- Registration Number
- 1530530
- FEI Number
- 3000718985
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15111 WHITE RD
- City
- MIDDLEFIELD
- State
- OH
- ZIP
- 44062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141850
Owner / Operator
- Firm Name
- TROY INNOVATIVE INSTRUMENTS, INC.
- Operator Number
- 9030647
- Address
- 15111 WHITE RD., --
- City
- Middlefield
- State
- OH
- Postal Code
- 44062
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-03 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2021-12-03 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-12-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-12-03 |
Proprietary Names
Canaveral Pedicle Screw System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)