FDA device listing
7.0 MUC SCREW 100MM X 16MM (44170016),7.0 MUC SCREW 100MM X 32MM (44170032),7.0 MUC SCREW 105MM X 16MM (44170516),7.0…
FDA device listing 1904311368 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 7.0 MUC SCREW 100MM X 16MM (44170016),7.0 MUC SCREW 100MM X 32MM (44170032),7.0 MUC SCREW 105MM X 16MM (44170516),7.0 MUC SCREW 105MM X 32MM (44170532),7.0 MUC SCREW 110MM X 16MM (44171016),7.0 MUC SCREW 110MM X 32MM (44171032),7.0 MUC SCREW 40MM X 16MM (44174016),7.0 MUC SCREW 45MM X 16MM (44174516),7.0 MUC SCREW 50MM X 16MM (44175016),7.0 MUC SCREW 55MM X 16MM (44175516),7.0 MUC SCREW 60MM 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