FDA device listing
3.5mm Pivot Driver (MO10321M),Adaptor Trial ASM XL (MO10371M) M-1435-2804,Calcar Planner (MO10324M) M-1500-1017,Cup…
FDA device listing 1237497015 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 3.5mm Pivot Driver (MO10321M),Adaptor Trial ASM XL (MO10371M) M-1435-2804,Calcar Planner (MO10324M) M-1500-1017,Cup Alignment Guide (MO10323M),Dome Impactor Size 1 (MO10325M) M-1500-2801,Dome Impactor Size 2 (MO10326M) M-1500-2802,Dome Impactor Size 3 (MO10327M) M-1500-3601,Drill Guide (MO10318M),Elevated Trial Liner Size 50x28 (MO10645M),Elevated Trial Liner Size 52x28 (MO10646M),Elevated Trial… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | LPH, LZO |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353, 888.3358 |
| 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