FDA device listing
12mm Drill Bit,1.5mm Drill Bit,2.4mm Flute Less Drill Bit,3.3mm OD X 20cm Cannulated Drill,3.5 OD X 20cm Cannulated…
FDA device listing 1166577238 · MedTech-LLC
Key facts
| Proprietary names | 12mm Drill Bit,1.5mm Drill Bit,2.4mm Flute Less Drill Bit,3.3mm OD X 20cm Cannulated Drill,3.5 OD X 20cm Cannulated Drill,5.5/6.0 MAS Lock Sleeve Screwdriver,Drill Bit 3.7mm,Drill Solid 1.3mm X 10cm, SS,Drill, Solid 1.6mm X 11cm, SS,Hammertoe 2.15mm X 70mm Cannulated Drill,OverDrill, Solid 2.0mm X 9cm, SS,Overdrill, Solid2.5mm X 10cm, SS,Retractor, Left Side,Tibia Coupled ARC Drill Template,Tibia… |
|---|---|
| Owner/operator | MedTech-LLC |
| Owner/operator number | 10043432 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | MEDTECH LLC |
| Establishment registrations | 3010123256 |
| FEI numbers | 3010123256 |
| 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