FDA Registration
Active
🇺🇸 United States
INNOVASIS, INC.
Reg #: 3004719693
·
FEI: 3004719693
·
Expires 2026
Products
20
Proprietary Names
46
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- INNOVASIS, INC.
- Registration Number
- 3004719693
- FEI Number
- 3004719693
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 614 E 3900 S
- City
- Millcreek
- State
- UT
- ZIP
- 84107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062151
Owner / Operator
- Firm Name
- Inno Holdings Inc.
- Operator Number
- 10094493
- Address
- 614 E 3900 S
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84107
- Country
- US
- Correspondent
- Michael Thomas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-12-03 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2025-12-03 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-03 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-12-03 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-12-03 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-12-03 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-12-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-12-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-12-03 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-12-03 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-12-03 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-12-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2025-12-03 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2025-12-03 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2025-12-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-12-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
Proprietary Names
T-Box PEEK VBR System
X-Box PEEK VBR System
TruView Light Cable
Innovasis Navigation Instruments
Vector M-S Navigation Instruments
CxHA PEEK Cervical IBF System
SpineWorks FixxSure X-Link
Endeavor Stand-Alone Cervical IBF System
Kestrel Buttress Plate System
SpineWorks Anterior Lumbar Device
SpineWorks ALD
Neuro & Craniofacial Fixation System
Excella II Spinal System
Excella III-D Spinal Deformity System
Excella MIS Spinal System
Excella 3 Spinal System
Opteryx Cervical Plate System
Excella M-S Navigation Instruments
Gibralt Spine System
Gibralt Posterior Cervical Spine System
Vector G-E Navigation Instruments
Excella G-E Navigation Instruments
PxHA PEEK IBF System
Excella-P Spinal System
Excella Spinal System
Innovasis Disc Prep
Excella-M Spinal System
SpineWorks Stansion Matrix
Pedicle Subtraction Osteotomy Set
PSO
AxTiHA Stand-Alone ALIF System
TxTiHA IBF System
HAtetracell-C Titanium Cervical IBF System
Oryx Cervical Plate System
Px PEEK IBF System
TxHA PEEK IBF System
LxHA PEEK Lateral IBF System
ICS
Innovasis Cranial System
TruView Lateral Retractor System
TruView Lateral Access System
AxHA Stand-Alone ALIF System
C-Box PEEK Cervical IBF System
Vector Pedicle Screw System
L-Box PEEK IBF System
A-Box PEEK IBF System
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device