FDA device listing
777755062 Darco Headed Scr 7.5 x 50mm 16mm,777756062 Darco Headed Scr 7.5 x 60mm 16mm,DARCO® HEADED SCR 6.5X50 16MM…
FDA device listing 1088225975 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 777755062 Darco Headed Scr 7.5 x 50mm 16mm,777756062 Darco Headed Scr 7.5 x 60mm 16mm,DARCO® HEADED SCR 6.5X50 16MM (777655062) |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HWC |
| Device names | HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| 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