FDA device listing
590112KG Tornier Perform Advanced Glenoid Keeled Drill Guide S/M,5901L12PG Tornier Perform Advanced Glenoid Pegged Drill…
FDA device listing 1220847858 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 590112KG Tornier Perform Advanced Glenoid Keeled Drill Guide S/M,5901L12PG Tornier Perform Advanced Glenoid Pegged Drill Guide S/M Left,5901L34PG Tornier Perform Advanced Glenoid Pegged Drill Guide L/XL Left,5901NRLG Large Reamer,5901NRLG TORNIER PERFORM ADVANCED GLENOID NEO REAMER ANATOMIC SPOKED LG,5901NRMD Medium Reamer,5901NRMD TORNIER PERFORM ADVANCED GLENOID NEO REAMER ANATOMIC SPOKED… |
|---|---|
| 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