FDA Registration
Active
🇺🇸 United States
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)
Reg #: 3026776
·
FEI: 1000135253
·
Expires 2026
Products
12
Proprietary Names
19
Establishment Types
1
Classifications
12
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Registration Details
- Registration Name
- VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)
- Registration Number
- 3026776
- FEI Number
- 1000135253
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15045 NE MASON ST.
- City
- Parkrose
- State
- OR
- ZIP
- 97230
- Country
- US
Owner / Operator
- Firm Name
- Avalign Instruments & Implants
- Operator Number
- 9008280
- Address
- 8727 Clinton Park Drive, --
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46825
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-06-06 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-06-06 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-11-12 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-09-30 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-08-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-08-19 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-11-08 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-08-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-08-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-08-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2019-08-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-01-31 |
Proprietary Names
DePuy Expedium Verse Navigation Driver - Shaft
Medtronic Drills, Burrs, Trephines & Accessories
Medtronic Catalyft LS Expandable Interbody System
DePuy Synthes NAV Drill Guide Assembly
Johnson&Johnson Orthopedic Stereotaxic Instrument
Zimmer Affixus
Medtronic Capstone R Spinal System
DePuy Synthes Trialtis Drill Sleeve
Orthopedic Manual Surgical
ES2 SPINAL SYSTEM
Reliance Lite
AVS ANCHOR-C CERVICAL CAGE SYSTEM
XIA III
ARIA
NEMCOMED ORTHOPEDIC
Prophecy Adapter 16MM Insert
Prophecy Adapter 18MM Insert
Prophecy C-Bracket Adapter
Prophecy Adapter Screw Adjust
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)