FDA Registration
Active
🇺🇸 United States
Excella II Spinal System
Reg #: 3004719693
·
FEI: 3004719693
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- INNOVASIS, INC.
- Registration Number
- 3004719693
- FEI Number
- 3004719693
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 614 E 3900 S
- City
- SALT LAKE CITY
- State
- UT
- ZIP
- 84107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102248
Owner / Operator
- Firm Name
- INNOVASIS, INC.
- Operator Number
- 9063224
- Address
- 614 EAST 3900 SOUTH, --
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84107
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2010-12-07 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2010-12-07 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2010-12-07 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2010-12-07 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2010-12-07 |
Proprietary Names
Excella II Spinal System
Ethos Spinal System
Excella MIS Spinal System
Excella 3 Spinal System
Excella III-D Spinal Deformity System
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device