FDA device listing
1456-7900 screwdriver,17436 Mod Shankdriver Sheath,2.0/2.4 Cannulated Drill Bit Tiger Cannulated 211-24-001,2.0 / 2.4 T8…
FDA device listing 1076738733 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 1456-7900 screwdriver,17436 Mod Shankdriver Sheath,2.0/2.4 Cannulated Drill Bit Tiger Cannulated 211-24-001,2.0 / 2.4 T8 Cannulated Driver Bit Tiger cannulated 211-24-003,3.0 / 4.0 T10 Cannulated Driver Bit Tiger Cannulated 211-40-003,371-01-30 (T-10 Screw Driver, AO Connection),371-01-33 Exac Loc Hex Driver,5.5mm Driver Tiger Large Cannulated Screw System 215-55-003,57702020 Driver Hex 2.0mm Mica… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HXX |
| Device names | HXX - Screwdriver |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245 |
| FEI numbers | 3025603301, 3033509898, 3036756245 |
| 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