FDA device listing
Cannula Holder,Cervical Cage Holder,DFN Plate Holder,Endcap Holder (For Humerus Nail),Guide Wire Holder (For AAN),Guide…
FDA device listing 1552518780 · Miraclus Orthotech Private Limited
Key facts
| Proprietary names | Cannula Holder,Cervical Cage Holder,DFN Plate Holder,Endcap Holder (For Humerus Nail),Guide Wire Holder (For AAN),Guide Wire Holder (For DFN),Guide Wire Holder (For EFSCN),Guide Wire Holder (For ML-Tibia),Guide Wire Holder (For PFAN),Guide Wire Holder (For SL-Tibia),Guide Wire Holding Device (For Expert Femur),Imaging Needle Cylindrical,Imaging Needle Holder (For MS-3),Imaging Needle… |
|---|---|
| Owner/operator | Miraclus Orthotech Private Limited |
| Owner/operator number | 10093149 |
| Product codes | HXK |
| Device names | HXK - Holder, Needle; Orthopedic |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | MIRACLUS ORTHOTECH PRIVATE LIMITED |
| Establishment registrations | 3038187464 |
| FEI numbers | 3038187464 |
| Establishment operations | 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