FDA Device Establishments · JSON-LD · Markdown
FEI 3004889950 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3004889950 |
|---|---|
| Owner / Operator | Straits Orthopaedics (Mfg) Sdn Bhd (#10048319) |
| Address | 2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, Bayan Lepas Pulau Pinang, 11920, MY |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KWS |
| Regulation § (21 CFR) | 888.3660 |
| Proprietary names | Turon Captured Screw, Trial Humeral Head (804-05-061); Turon Proximal Humeral Protector,Size Large (804-05-149); Turon, Stop Drill, 5mm (804-25-147); Turon, Glenoid Sizing Guide, Size 42 (804-25-102); Turon Neck Trial,7.5 Degree Angled (804-15-005); Turon Proximal Humeral Protector,Size Small (804-05-148); Turon Planar Guide, Angled Neck (804-05-053); Turon, Drill Guide Lug (804-25-129); Turon, Drill Guide Pusher (804-25-132); Turon, 38mm Glenoid, Peg Drill Guide (804-25-124) |
Source: openFDA. Public-domain (CC0).