FDA Registration
Active
🇺🇸 United States
Viant AS&O Holdings, LLC
Reg #: 1319429
·
FEI: 1000120314
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Viant AS&O Holdings, LLC
- Registration Number
- 1319429
- FEI Number
- 1000120314
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3902 CALIFORNIA RD.
- City
- ORCHARD PARK
- State
- NY
- ZIP
- 14127
- Country
- US
Owner / Operator
- Firm Name
- Viant Medical, LLC
- Operator Number
- 9043339
- Address
- 2 Hampshire Street, Suite 202
- City
- Foxborough
- State
- MA
- Postal Code
- 02035
- Country
- US
- Correspondent
- David - Rose
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-03-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-12-12 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-12-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-12-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-12-12 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2018-12-12 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2020-06-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-12-12 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-12-12 |
Proprietary Names
VIPER PRIME X-Tab 4.5X35MM Ti Rod
EXPEDIUM COCR Rod, Pre-Lordosed
EXPEDIUM Spinal Rod
EXPEDIUM Ti Dual Diameter Rod
Revolution Radial Head
STORZ Microflow and Standard Phacoemulsification Needle
Phaco Chop Needles
Needle MICROFLOW 30 Degree
Vitality Spinal Fixation System
EXPEDIUM Straight Rod w/ Hex End 300 and 600MM
LOW PROFILE LOCKING SCREW TI 3.5MM X 10MM
LOW PROFILE LOCKING SCREW TI 3.5MM X 12MM
LOW PROFILE LOCKING SCREW SS 3.5MM X 38MM
7MM WASHER AR-8870W
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)