FDA device listing
Bengal, Bengal Stackable, Concorde Bullet, Concorde Inline, Cougar, Cougar LS Lateral
FDA device listing 1252296285 · Jabil Inc.
Key facts
| Proprietary names | Bengal, Bengal Stackable, Concorde Bullet, Concorde Inline, Cougar, Cougar LS Lateral |
|---|---|
| Owner/operator | Jabil Inc. |
| Owner/operator number | 9074019 |
| Product codes | MAX, MQP, ODP |
| Device names | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar, MQP - Spinal Vertebral Body Replacement Device, ODP - Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3060, 888.3080 |
| Review panels | Orthopedic |
| Registered establishments | Jabil Switzerland Manufacturing GmbH (Le Locle) |
| Establishment registrations | 3015831087 |
| FEI numbers | 3015831087 |
| 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