FDA device listing
Neo Cage System
FDA device listing 1380916624 · SK Pharma Logistics GmbH
Key facts
| Proprietary names | Neo Cage System |
|---|---|
| Owner/operator | SK Pharma Logistics GmbH |
| Owner/operator number | 10091163 |
| Premarket submissions | K181048 |
| Product codes | MAX |
| Device names | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3080 |
| Review panels | Orthopedic |
| Registered establishments | SK PHARMA LOGISTICS GMBH |
| Establishment registrations | 3017155536 |
| FEI numbers | 3017155536 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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