FDA device listing
4 Hole Pin Clamp (71067375),6 Hole Pin Clamp (71067376),Ankle Clamp Bolt (81015393),Ankle Clamp Moving Jaw…
FDA device listing 1393456644 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 4 Hole Pin Clamp (71067375),6 Hole Pin Clamp (71067376),Ankle Clamp Bolt (81015393),Ankle Clamp Moving Jaw (81015391),Clamp Bolt-Small (81015394),Conversion Kit Clamp Assembly (81106483),DART-FIRE™ COMPRESSION SCREW HEADED SCREW 3.5MM X 58MM (D1N35058S),Freedom Bolt Joint Clamp (71067382),Knob Pin (71062016 Mini Double Pin Clamp with Ball Joint (81011421/0),Mini Clamp Jam Nut (71062016) Mini… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HWC, KTT |
| Device names | HWC - Screw, Fixation, Bone, KTT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 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