FDA Registration
Active
🇺🇸 United States
Orthros Posterior Stabilization System
Reg #: 3010197239
·
FEI: 3010197239
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CAMBER SPINE TECHNOLOGIES
- Registration Number
- 3010197239
- FEI Number
- 3010197239
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 501 Allendale Rd
- City
- King of Prussia
- State
- PA
- ZIP
- 19406
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133366
Owner / Operator
- Firm Name
- Camber Spine/Medical Technologies
- Operator Number
- 10043961
- Address
- 501 Allendale Rd.
- City
- King of Prussia
- State
- PA
- Postal Code
- 19406
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-05-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-05-02 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-05-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-05-02 |
Proprietary Names
Orthros Posterior Stabilization System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility