FDA Registration
Active
🇺🇸 United States
REFORM HA COATED PEDICLE SCREW SYSTEM
Reg #: 3005739886
·
FEI: 3005739886
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Precision Spine, Inc.
- Registration Number
- 3005739886
- FEI Number
- 3005739886
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2050 Executive Dr
- City
- Pearl
- State
- MS
- ZIP
- 39208
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151422
Owner / Operator
- Firm Name
- Spinal USA, Inc.
- Operator Number
- 9087328
- Address
- 2050 Executive Drive, --
- City
- Pearl
- State
- MS
- Postal Code
- 39208
- Country
- US
- Correspondent
- Michael C Dawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-01-24 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-01-24 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-01-24 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-01-24 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-01-24 |
Proprietary Names
REFORM HA COATED PEDICLE SCREW SYSTEM
Establishment Types
Manufacture Medical Device