FDA device listing
Bolt, 12 mm (RR1200),BOLT, 16 MM (RR1600),BOLT, 20 MM (RR2000),Conical Washer (RR2201),HALF PIN 3.0MMX80MM 20MM THREAD…
FDA device listing 1679218084 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Bolt, 12 mm (RR1200),BOLT, 16 MM (RR1600),BOLT, 20 MM (RR2000),Conical Washer (RR2201),HALF PIN 3.0MMX80MM 20MM THREAD (RR302080),MALE POST, 1 HOLE (RR10P),MALE POST, 2 HOLE (RR20P),Male Post, 4 Hole (RR40P),NUT, 10 MM (RR1001),Plate, 2 Hole (RR200PL),Sidekick® Half Pin 5 x 25 Tin 180mm Long (RR5025TN),Sidekick® Half Pin 5 x 30 Tin 180mm Long (RR5030TN),Slotted Washer (RR2101),Square Nut… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | JDW, KTT |
| Device names | JDW - Pin, Fixation, Threaded, 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