FDA device listing
Dia2.6mm Non-Locking Ti Screw - 10mm Long (STX-2610),Dia 2.6mm Non-Locking Ti Screw - 12mm Long (STX-2612),Dia 2.6mm…
FDA device listing 1430705731 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Dia2.6mm Non-Locking Ti Screw - 10mm Long (STX-2610 ),Dia 2.6mm Non-Locking Ti Screw - 12mm Long (STX-2612),Dia 2.6mm Non-Locking Ti Screw - 20mm Long (STX-2620),Dia 2.6mm Non-Locking Ti Screw - 22mm Long (STX-2622),DR28-095C Dia 2.8mm x 95mm Drill Bit Calibrated,Volar Plate Narrow Left 4H x 21 x 53mm (DRPX-N0453L) |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HRS |
| Device names | HRS - Plate, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| 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