FDA device listing
Calcar Reamer Size 1, 2, 3 (81094848, 71365023),Calcar Reamer Size 4,5 (81094849, 71365025),HIGH FLEXION TIBIAL IMPACTOR…
FDA device listing 1520835240 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Calcar Reamer Size 1, 2, 3 (81094848, 71365023),Calcar Reamer Size 4,5 (81094849, 71365025),HIGH FLEXION TIBIAL IMPACTOR BUMPER SIZE 1-2 (81072005),HIGH FLEXION TIBIAL IMPACTOR BUMPER SIZE 3-8 (81072006) |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | JDG, JDI, JDJ, JDQ, KWL, KWY, KWZ, LPH, LWJ, LZO, LZY, MBL and 1 more |
| Device names | JDG - Prosthesis, Hip, Femoral Component, Cemented, Metal, JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, JDJ - Mesh, Surgical, Acetabular, Hip, Prosthesis, JDQ - Cerclage, Fixation, KWL - Prosthesis, Hip, Hemi-, Femoral, Metal, KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, LZY - Prosthesis, Hip, Hemi-, Femoral, Metal Ball, MBL - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous and 1 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.3300, 888.3010, 888.3310, 888.3350, 888.3353, 888.3358, 888.3360, 888.3390 |
| Review panels | General & Plastic Surgery, 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