FDA device listing
10mm PL Trial,10mm TL Trial,6mm PL Trial,6mm TL Trial,8mm PL Trial,8mm TL Trial,Graft Insertion Cannula,Graft Insertion…
FDA device listing 1099756188 · Engineered Medical Systems, LLC
Key facts
| Proprietary names | 10mm PL Trial,10mm TL Trial,6mm PL Trial,6mm TL Trial,8mm PL Trial,8mm TL Trial,Graft Insertion Cannula,Graft Insertion Pusher,Insertion Handle End Cap,Insertion Handle Rotator Knob,Instrument Tray Base,Instrument Tray Insert,Instrument Tray Lid,PL Insertion Handle,PL Insertion Handle Inner Shaft,PL Instrument Set (Long Trial Handles),PL Tubing Set (STERILE),Prep Block,Slap Hammer,TL Insertion… |
|---|---|
| Owner/operator | Engineered Medical Systems, LLC |
| Owner/operator number | 10042524 |
| 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 | Engineered Medical Systems, LLC |
| Establishment registrations | 3009973336 |
| FEI numbers | 3009973336 |
| 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