FDA device listing
0.9mm K-Wire, 6 Inch Length, Trocar-Blunt (FO-2013-096),1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT (FO-2013-116),12mm…
FDA device listing 1196723575 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 0.9mm K-Wire, 6 Inch Length, Trocar-Blunt (FO-2013-096),1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT (FO-2013-116),12mm Planer (FO-2021-12),1.6mm K-Wire, 6 Inch Length, Trocar-Blunt (FO-2013-166),16mm Planer (FO-2021-16),20mm Planer (FO-2021-20),24mm Planer (FO-2021-24),3.5MM CANN SCREW CANNULATED DRILL 2.5MM (FPS) - OS200325,DRILL 3.0MM X 150MM CANNULATED QC - OS200326,Punch VI Size 24 (FO-2007-24) |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | JDR |
| Device names | JDR - Staple, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| 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