FDA Registration
Active
🇺🇸 United States
Rexious, Statera, Statera-M Spinal Fixation System
Reg #: 3009014637
·
FEI: 3009014637
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DIO MEDICAL CORPORATION
- Registration Number
- 3009014637
- FEI Number
- 3009014637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2900 Potshop Ln, Suite 200
- City
- Eagleville
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232586
Owner / Operator
- Firm Name
- Dio Medical Corp.
- Operator Number
- 10036249
- Address
- 2100 Campus Lane, Suite 100
- City
- East Norriton
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Milan George
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-03-07 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-03-07 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-03-07 |
Proprietary Names
Rexious, Statera, Statera-M Spinal Fixation System
Establishment Types
Repack or Relabel Medical Device