FDA device listing
Mesh Cage Implant Cutter-Large,Mesh Cage Implant Cutter-Small,Nail Cutter,Reduction Screw Tip Breaker (For MS-3),Rod…
FDA device listing 2014053356 · Miraclus Orthotech Private Limited
Key facts
| Proprietary names | Mesh Cage Implant Cutter-Large,Mesh Cage Implant Cutter-Small,Nail Cutter,Reduction Screw Tip Breaker (For MS-3),Rod Cutter (For PCF),Tip Breaker (For MIS-II),Wire Cutter,1.5/2.0/3.0mm ,200mm Length,Wire Cutter ,Tungsten Carbide Inserter,160mm Length,Wire Cutter ,Tungsten Carbide Inserter, 230mm Length |
|---|---|
| Owner/operator | Miraclus Orthotech Private Limited |
| Owner/operator number | 10093149 |
| Product codes | FZT |
| Device names | FZT - Cutter, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| 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