FDA device listing
5100-010-930 COLLET PIN,5100-010-957 TORQUE RING,5100-010-958 TORQUE PIN,5407-120-831 T-SPACER,5407-120-832 SHORT FRONT…
FDA device listing 1073704221 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 5100-010-930 COLLET PIN,5100-010-957 TORQUE RING,5100-010-958 TORQUE PIN,5407-120-831 T-SPACER,5407-120-832 SHORT FRONT SPACER,5407-120-833 REAR SPACER,5407-120-835 LONG FRONT SPACER,5407-120-836 CURVED LONG SPACER |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | ERL, HBE |
| Device names | ERL - Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, HBE - Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4250, 882.4310 |
| Review panels | Ear, Nose, & Throat, Neurology |
| 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