FDA device listing
81064447 Long Stem 22mm (100mm),Distal Femoral Wedge Size 3 15mm (81011003),FEMORAL L-WEDGE SIZE 3 15mm x 5mm…
FDA device listing 2071467425 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 81064447 Long Stem 22mm (100mm),Distal Femoral Wedge Size 3 15mm (81011003),FEMORAL L-WEDGE SIZE 3 15mm x 5mm (81011027SHR),Legion Oncology Diaphyseal Segment 100mm (81116048),Legion Oncology Diaphyseal Segment 35mm (81116041),Legion Oncology Diaphyseal Segment 60mm (81116044),Long Stem 22mm (100mm) (81064447) |
|---|---|
| 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