FDA Registration
Active
🇺🇸 United States
Sintea USA
Reg #: 1066481
·
FEI: 3003428720
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SINTEA PLUSTEK, LLC
- Registration Number
- 1066481
- FEI Number
- 3003428720
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 407 Lincoln Road Suite 11B
- City
- Miami Beach
- State
- FL
- ZIP
- 33139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112611
Owner / Operator
- Firm Name
- Sintea USA, LLC
- Operator Number
- 10031158
- Address
- 407 Lincoln Road, Suite 11B
- City
- Miami Beach
- State
- FL
- Postal Code
- 33139
- Country
- US
- Correspondent
- Guido Zorzoli
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-12-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-12-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2020-12-31 |
Proprietary Names
Sintea USA
Establishment Types
Manufacture Medical Device