FDA Registration
Active
🇺🇸 United States
IONz IntraHeal Trochanteric Fixation System
Reg #: 3015946784
·
FEI: 3015946784
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ORTHONOVIS, INC.
- Registration Number
- 3015946784
- FEI Number
- 3015946784
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Hargrove Grade, 2F
- City
- Palm Coast
- State
- FL
- ZIP
- 32137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203811
Owner / Operator
- Firm Name
- OrthoNovis, Inc.
- Operator Number
- 10061543
- Address
- 1 Hargrove Grade, 2F
- City
- Palm Coast
- State
- FL
- Postal Code
- 32137
- Country
- US
- Correspondent
- Ken West
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-04-27 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-04-27 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2023-04-27 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2023-04-27 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-04-27 |
Proprietary Names
IONz IntraHeal Trochanteric Fixation System
Establishment Types
Repack or Relabel Medical Device