FDA device listing
Cervical Inserter 01C00003,Footprint Sizer - 14.5mm X 12mm 02C00210,Footprint Sizer - 16.5mm X 14mm 02C00212,Mallet…
FDA device listing 1298986011 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Cervical Inserter 01C00003,Footprint Sizer - 14.5mm X 12mm 02C00210,Footprint Sizer - 16.5mm X 14mm 02C00212,Mallet - Small 08C00019,POLYAXIAL SCREW DRIVER ASSEMBLY 430-1000,Ring Handle Inserter - Cervical Tissue 01C00004,STRAIGHT BONE PROBE 430-1001,Tamp - Curved Cervical - Delrin Tip 07C00037,Tamp - Straight Cervical - Delrin Tip 07C00038,VBR Caliper 20C00003,VBR Graft Packer - Block… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | MQP, PLR |
| Device names | MQP - Spinal Vertebral Body Replacement Device, PLR - Spinal Vertebral Body Replacement Device - Cervical |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3060 |
| 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