FDA device listing
11.0 Tap for 12.0 Screw (Q070-T012),13.0 Tap for 14.0 Screw (Q070-T014),4.0 Drill for 8.0 Screw (Q070-D008),4.0 Drill…
FDA device listing 1190982603 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 11.0 Tap for 12.0 Screw (Q070-T012),13.0 Tap for 14.0 Screw (Q070-T014),4.0 Drill for 8.0 Screw (Q070-D008),4.0 Drill For 8.0 Screw (Q070-DS08),7.0 Drill for 12.0 Screw (Q070-D012),7.0 Drill For 12.0 Screw (Q070-DS12),7.0 Tap for 8.0 Screw (Q070-T008),9.0 Drill for 14.0 Screw (Q070-D014),Bone Funnel-Hexalobe, Triton (Q070-0016),Bone Plunger, Triton (Q070-0018),Dilator 1, Triton (Q070-0001),Dilator… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | OUR |
| Device names | OUR - Sacroiliac Joint Fixation |
| 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