FDA Registration
Active
🇮🇹 Italy
Implant Spine System
Reg #: 3007353762
·
FEI: 3007353762
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LINCOTEK TRENTO S.P.A
- Registration Number
- 3007353762
- FEI Number
- 3007353762
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Al Dos de La Roda, 60
- City
- Cire di Pergine Trento
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K143731
Owner / Operator
- Firm Name
- Lincotek Trento S.P.A
- Operator Number
- 10027475
- Address
- Via Al Dos de La Roda, 60
- City
- Cire' di Pergine
- State
- Trento
- Postal Code
- I-38057
- Country
- IT
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-10-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-10-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-10-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-10-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-10-31 |
Proprietary Names
Implant Spine System
Establishment Types
Repack or Relabel Medical Device