FDA device listing
GFS Sterile Screw, 28mm,GFS Sterile Screw, 30mm,GFS Sterile Screw, 32mm,GFS Sterile Screw, 34mm,GFS Sterile Screw…
FDA device listing 1739648635 · TAG Medical products corporation LTD
Key facts
| Proprietary names | GFS Sterile Screw, 28mm,GFS Sterile Screw, 30mm,GFS Sterile Screw, 32mm,GFS Sterile Screw, 34mm,GFS Sterile Screw, 36mm,GFS Sterile Screw, 38mm,GFS Sterile Screw, 40mm,GFS Sterile Screw, 42mm,GFS Sterile Screw, 44mm,GFS - Sterile Screws and Top Hat,GFS Sterile Top Hat |
|---|---|
| Owner/operator | TAG Medical products corporation LTD |
| Owner/operator number | 9004870 |
| Premarket submissions | K253858 |
| Product codes | HWC |
| Device names | HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | T.A.G. MEDICAL PRODUCTS CORPORATION LTD |
| Establishment registrations | 8043971 |
| FEI numbers | 1000272060 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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