FDA Registration
Active
🇺🇸 United States
Paragon 28
Reg #: 3012491394
·
FEI: 3012491394
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Summit Orthopedic Technologies Inc.
- Registration Number
- 3012491394
- FEI Number
- 3012491394
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2975 Horseshoe Drive South, Suite 100
- City
- Naples
- State
- FL
- ZIP
- 34104
- Country
- US
Regulatory Submissions
- 510(k) Number
- K124058
Owner / Operator
- Firm Name
- Summit Orthopedic Technologies Inc.
- Operator Number
- 10051828
- Address
- 2975 Horseshoe Drive South, Suite 100
- City
- Naples
- State
- FL
- Postal Code
- 34104
- Country
- US
- Correspondent
- Jason K Blake
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2020-03-25 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2020-03-25 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-03-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-03-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-03-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-03-25 |
Proprietary Names
Paragon 28
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)