FDA device listing
Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali…
FDA device listing 2068489313 · VB Spine, LLC
Key facts
| Proprietary names | Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest,Cascadia Interbody System,Drill Bit,General Instruments,Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini,NAPA Access System,Orthopaedic Manual Instrumentation,ORTHOPEDIC MANUAL,Q Interbody Instruments,Screw Insertion Sleeve,Terra Nova, Ravine… |
|---|---|
| Owner/operator | VB Spine, LLC |
| Owner/operator number | 10093189 |
| 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 | K2M, INC., STRYKER SPINE |
| Establishment registrations | 9617544, 3004024955, 3004774118 |
| FEI numbers | 3003112432, 3004024955, 3008599177 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, 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