FDA device listing
15600 Femoral Cutting Block,18600 Trigger Stylus,18900 EMPOWR FEMORAL SIZER ADAPTER,19900 RESECTION CHECK TOOL,20100…
FDA device listing 1218460581 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 15600 Femoral Cutting Block,18600 Trigger Stylus,18900 EMPOWR FEMORAL SIZER ADAPTER,19900 RESECTION CHECK TOOL,20100 ADJUSTABLE MOUNT 1,20200 ADJUSTABLE MOUNT 2,20300 TIBIAL REFERENCE MOUNT, LEFT,20400 TIBIAL REFERENCE MOUNT, RIGHT,21000 FLEX JACK,IN-10200-001 Assy, reference amount,IN-10400-001 TRACKER D,IN-10500-001 IMPACTOR V-BLOCK ASSY,IN-10600-001 TRACKER B,IN-14700-001 LANDMARK… |
|---|---|
| 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