FDA Registration
Active
🇺🇸 United States
ISS Integrated Spine System
Reg #: 1828464
·
FEI: 1828464
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SYMMETRY MEDICAL MANUFACTURING INC.
- Registration Number
- 1828464
- FEI Number
- 1828464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 486 West 350 North
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061524
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, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-20 |
Proprietary Names
ISS Integrated Spine System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)