FDA device listing
EVOLVE™ HEAD 20MM +2 (496H220),EVOLVE™ HEAD 20MM +4 (496H420),EVOLVE™ HEAD 20MM (496H020),EVOLVE™ HEAD 22MM +2…
FDA device listing 1182240097 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | EVOLVE™ HEAD 20MM +2 (496H220),EVOLVE™ HEAD 20MM +4 (496H420),EVOLVE™ HEAD 20MM (496H020),EVOLVE™ HEAD 22MM +2 (496H222),EVOLVE™ HEAD 22MM +4 (496H422),EVOLVE™ HEAD 22MM (496H022),EVOLVE™ HEAD 24MM +2 (496H224),EVOLVE™ HEAD 24MM +4 (496H424),EVOLVE™ HEAD 24MM (496H024),EVOLVE™ HEAD 26MM +2 (496H226),EVOLVE™ HEAD 26MM +4 (496H426),EVOLVE™ HEAD 26MM (496H026),EVOLVE™ HEAD 28MM +2 (496H228),EVOLVE™… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | KWI |
| Device names | KWI - Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3170 |
| 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