FDA device listing
ARIA,AVS ANCHOR-C CERVICAL CAGE SYSTEM,ES2 SPINAL SYSTEM,NEMCOMED ORTHOPEDIC,Orthopedic Manual Surgical,Prophecy Adapter…
FDA device listing 1845677105 · Avalign Instruments & Implants
Key facts
| Proprietary names | ARIA,AVS ANCHOR-C CERVICAL CAGE SYSTEM,ES2 SPINAL SYSTEM,NEMCOMED ORTHOPEDIC,Orthopedic Manual Surgical,Prophecy Adapter 16MM Insert,Prophecy Adapter 18MM Insert,Prophecy Adapter Screw Adjust,Prophecy C-Bracket Adapter,Reliance Lite,XIA III |
|---|---|
| Owner/operator | Avalign Instruments & Implants |
| Owner/operator number | 9008280 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Avalign Instruments & Implants, VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) |
| Establishment registrations | 3026776, 3006128100 |
| FEI numbers | 1000135253, 3006128100 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database