FDA device listing
3.5 mm cortical screw, bone plate system,screw fixation system,cannulated screws,4.5 mm cortical screws,AUXEIN- HRS…
FDA device listing 1683667720 · Auxein Medical Pvt Ltd
Key facts
| Proprietary names | 3.5 mm cortical screw, bone plate system,screw fixation system,cannulated screws,4.5 mm cortical screws,AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bon,AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bone |
|---|---|
| Owner/operator | Auxein Medical Pvt Ltd |
| Owner/operator number | 10046810 |
| Premarket submissions | K141680 |
| Product codes | HRS, HWC |
| Device names | HRS - Plate, Fixation, Bone, HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | Auxein medical Private limited |
| Establishment registrations | 3010303097 |
| FEI numbers | 3010303097 |
| 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