FDA device listing
KIC-DND-0100-1 ASM CUT JIG,KIC-DND-0100-2 ASM ADJUSTMENT JIG,KIC-DND-0100-3 ASM Fixation Frame,KIC-DND-0104-A ASM…
FDA device listing 1926850987 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | KIC-DND-0100-1 ASM CUT JIG,KIC-DND-0100-2 ASM ADJUSTMENT JIG,KIC-DND-0100-3 ASM Fixation Frame,KIC-DND-0104-A ASM HORSESHOE FIXATION A,KIC-DND-0104-B ASM HORSESHOE FIXATION B,KIC-DND-0105 UNIVERSAL HORSESHOE FIXATION,KIC-DND-0120 RESECTION PLANE 90,KIC-DND-0145 EMPOWR SIZER UTC ADAPTOR |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | OLO |
| Device names | OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | 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