FDA device listing
Turon™, 38mm Glenoid, Peg Drill Guide (804-25-124),Turon Captured Screw, Trial Humeral Head (804-05-061),Turon™, Drill…
FDA device listing 1971503149 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Turon™, 38mm Glenoid, Peg Drill Guide (804-25-124),Turon Captured Screw, Trial Humeral Head (804-05-061),Turon™, Drill Guide Lug (804-25-129),Turon™, Drill Guide Pusher (804-25-132),Turon™, Glenoid Sizing Guide, Size 42 (804-25-102),Turon™ Neck Trial,7.5 Degree Angled (804-15-005),Turon™ Planar Guide, Angled Neck (804-05-053),Turon™ Proximal Humeral Protector,Size Large (804-05-149),Turon™… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | KWS |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660 |
| 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