FDA Registration
Active
🇺🇸 United States
Thoracolumbosacral pedicle screw system
Reg #: 1221053
·
FEI: 1221053
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SYMMETRY MEDICAL, INC. - MANCHESTER
- Registration Number
- 1221053
- FEI Number
- 1221053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 253 Abby Rd
- City
- MANCHESTER
- State
- NH
- ZIP
- 03103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152248
Owner / Operator
- Firm Name
- Tecomet
- Operator Number
- 1828464
- Address
- 170 New Boston Street, --
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-09-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-09-05 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-09-05 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2023-09-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-09-05 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-05 |
Proprietary Names
Thoracolumbosacral pedicle screw system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)