FDA device listing
138470 HEADED SCREW 4.0MM X [TAB] DART-RIRE COMPRESSION,138491 HEADED SCREW 4.0MM X [TAB] DART-RIRE…
FDA device listing 1826165442 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 138470 HEADED SCREW 4.0MM X [TAB] DART-RIRE COMPRESSION,138491 HEADED SCREW 4.0MM X [TAB] DART-RIRE COMPRESSION,D1N20010S HEADED SCREW 2.0MM X 10MM,D1N20012S HEADED SCREW 2.0MM X 12MM,D1N20014S HEADED SCREW 2.0MM X 14MM,D1N20016S HEADED SCREW 2.0MM X 16MM,D1N20018S HEADED SCREW 2.0MM X 18MM,D1N20020S HEADED SCREW 2.0MM X 20MM,D1N20022S HEADED SCREW 2.0MM X 22MM,D1N20024S HEADED SCREW 2.0MM X… |
|---|---|
| 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