FDA device listing
2.4mm Drill Sleeve,Back Drill 4.5 X 10.0mm,Back Drill 4.5 X 7.0mm,Back Drill 4.5 X 8.0mm,Back Drill 4.5 X 8.5mm,Back…
FDA device listing 1867563897 · TAG Medical products corporation LTD
Key facts
| Proprietary names | 2.4mm Drill Sleeve,Back Drill 4.5 X 10.0mm,Back Drill 4.5 X 7.0mm,Back Drill 4.5 X 8.0mm,Back Drill 4.5 X 8.5mm,Back Drill 4.5 X 9.0mm,Back Drill 4.5 x 9.5mm,Back Drill 6.0 x 11.0mm,Back Drill Femoral Guide Arm Right,Back Drill Guide Bullet ID 4.5mm,Back Drill Guide Bullet ID 6.0mm,Back Drill Sleeve,Back Drill Tibial Guide to Point,Bullet, 2.4mm,Bullet 2.4mm ID,FlipCutter® III Drill,Meniscal Root… |
|---|---|
| Owner/operator | TAG Medical products corporation LTD |
| Owner/operator number | 9004870 |
| Product codes | HTO |
| Device names | HTO - Reamer |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| 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
- 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