FDA device listing
Special Reduced Diameter T7 Cannulated Driver SMS0068101,Special Valor™ Nail Centering Dynamic Tube SMS00253,Valor® Nail…
FDA device listing 1975762110 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Special Reduced Diameter T7 Cannulated Driver SMS0068101,Special Valor™ Nail Centering Dynamic Tube SMS00253,Valor® Nail 3.0mm K-Wire (4150004025),VALOR® SCREW 5.0MM X 100MM LEN (4151150100),VALOR® SCREW 5.0MM X 20MM LEN (4151150020),VALOR® SCREW 5.0MM X 25MM LEN (4151150025),VALOR™ SCREW 5.0MM X 30MM LEN (4151150030),VALOR™ SCREW 5.0MM X 35MM LEN (4151150035),VALOR® SCREW 5.0MM X 40MM LEN… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HSB |
| Device names | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3020 |
| 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