FDA device listing
and lumbar in K212524,Avalign Delivery Systems does not manufacture intervertebral fusion device with bone graft…
FDA device listing 1742358413 · Avalign Delivery Systems Division
Key facts
| Proprietary names | and lumbar in K212524,Avalign Delivery Systems does not manufacture intervertebral fusion device with bone graft, lumbar. This listing is,because Medtronic cases / trays are registered as accessories to the intervertebral fusion device with bone graft, |
|---|---|
| Owner/operator | Avalign Delivery Systems Division |
| Owner/operator number | 9026184 |
| Product codes | MAX, OLO, OVD |
| Device names | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar, OLO - Orthopedic Stereotaxic Instrument, OVD - Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560, 888.3080 |
| Review panels | Neurology, Orthopedic |
| Registered establishments | Avalign Delivery Systems Division |
| Establishment registrations | 1835444 |
| FEI numbers | 3000717687 |
| 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