FDA device listing
CrossOver Cross Connectors,DePuy PULSE Thoracolumbar Screw System,EXPEDIUM Fenestrated Screw System,EXPEDIUM SFX Cross…
FDA device listing 1284708035 · Medos International SARL
Key facts
| Proprietary names | CrossOver Cross Connectors,DePuy PULSE Thoracolumbar Screw System,EXPEDIUM Fenestrated Screw System,EXPEDIUM SFX Cross Connectors,EXPEDIUM Spine System,EXPEDIUM VERSE Spine System,E-Z Link Cross Connectors,ISOLA Spine System,MONARCH Spine System,MOSS MIAMI Spine System,TiMX Low Back System |
|---|---|
| Owner/operator | Medos International SARL |
| Owner/operator number | 10031083 |
| Premarket submissions | K191212 |
| Product codes | JDN, JDQ, KWP, KWQ, NKB, PGM |
| Device names | JDN - Implant, Fixation Device, Spinal, JDQ - Cerclage, Fixation, KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, NKB - Thoracolumbosacral Pedicle Screw System, PGM - Growing Rod System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3010, 888.3050, 888.3060, 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | MEDOS INTERNATIONAL SARL |
| Establishment registrations | 3008114965 |
| FEI numbers | 3008114965 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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