FDA device listing
K-Wires,Merete Cannulated PCS Plate Compression Screw,Merete CS Cortical Screw dia 3.0 mm fully / short threaded,Merete…
FDA device listing 1228304891 · Aristotech Industries GmbH
Key facts
| Proprietary names | K-Wires,Merete Cannulated PCS Plate Compression Screw,Merete CS Cortical Screw dia 3.0 mm fully / short threaded,Merete CS Cortical Screw dia 3.5 mm fully / short threaded,Merete Style 10 Locking Bone Plate III (MetaFix Plantar BG10 Plate),Merete Style 11 Locking Bone Plate III (MetaFix" PlantarMAX" Plate),Merete Style 12 Locking Bone Plate III (MetaFix I Plate),Merete Style 13 Locking Bone Plate… |
|---|---|
| Owner/operator | Aristotech Industries GmbH |
| Owner/operator number | 10053573 |
| Product codes | HRS, HTY, HWC |
| Device names | HRS - Plate, Fixation, Bone, HTY - Pin, Fixation, Smooth, HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | Aristotech Industries GmbH |
| Establishment registrations | 3014314623 |
| FEI numbers | 3014314623 |
| Establishment operations | Contract 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