FDA device listing
71420700 FEM POST WEDGE SIZE 1-2 X-SHORT,FEM POST WEDGE SIZE 1-2 LONG 71420678,JII Porous Modular Femoral Lug…
FDA device listing 1726744635 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 71420700 FEM POST WEDGE SIZE 1-2 X-SHORT,FEM POST WEDGE SIZE 1-2 LONG 71420678,JII Porous Modular Femoral Lug (81113950),POSTERIOR FEMORAL WEDGE SIZE 1 - 2 5mm SHORT 71420686,Primary Femoral Lug (81064946),TIB WEDGE SIZE 1-2 71420746 |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | JWH |
| Device names | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3560 |
| 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