FDA device listing
ADULT LIMB RECONSTRUCTION SYSTEM,ADVANCED LIMB RECONSTRUCTION SYSTEM,BONE SCREWS,DYNAMIC AXIAL FIXATOR,ELBOW…
FDA device listing 1438260842 · ORTHOFIX SRL
Key facts
| Proprietary names | ADULT LIMB RECONSTRUCTION SYSTEM,ADVANCED LIMB RECONSTRUCTION SYSTEM,BONE SCREWS,DYNAMIC AXIAL FIXATOR,ELBOW FIXATOR,MINIRAIL SYSTEM,PAEDIATRIC LIMB RECONSTRUCTION SYSTEM,PELVIC FIXATOR,PENNIG DYNAMIC WRIST FIXATOR,PENNIG MINIFIXATOR,PERTROCHANTERIC FIXATOR,PREFIX FIXATOR,PROCALLUS FIXATOR,RADIOLUCENT WRIST FIXATOR,SMALL BLUE D.A.F.,TITANIUM SCREWS,XCALIBER BONE SCREWS,XCALIBER EXTERNAL FIXATOR |
|---|---|
| Owner/operator | ORTHOFIX SRL |
| Owner/operator number | 9011783 |
| Premarket submissions | K955848 |
| Product codes | JDW |
| Device names | JDW - Pin, Fixation, Threaded |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | ORTHOFIX SRL |
| Establishment registrations | 9680825 |
| FEI numbers | 3002807827 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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