FDA device listing
TPRLC 133 FP TYPE1 PPS HO 10.0,TPRLC 133 FP TYPE1 PPS HO 11.0,TPRLC 133 FP TYPE1 PPS HO 12.0,TPRLC 133 FP TYPE1 PPS HO…
FDA device listing 1664126363 · SHANGHAI JPY ION-TECH CO., LTD.
Key facts
| Proprietary names | TPRLC 133 FP TYPE1 PPS HO 10.0,TPRLC 133 FP TYPE1 PPS HO 11.0,TPRLC 133 FP TYPE1 PPS HO 12.0,TPRLC 133 FP TYPE1 PPS HO 13.0,TPRLC 133 FP TYPE1 PPS HO 14.0,TPRLC 133 FP TYPE1 PPS HO 15.0,TPRLC 133 FP TYPE1 PPS HO 16.0,TPRLC 133 FP TYPE1 PPS HO 17.0,TPRLC 133 FP TYPE1 PPS HO 20.0,TPRLC 133 FP TYPE1 PPS HO 22.0,TPRLC 133 FP TYPE1 PPS HO 24.0,TPRLC 133 FP TYPE1 PPS HO 7.0,TPRLC 133 FP TYPE1 PPS HO… |
|---|---|
| Owner/operator | SHANGHAI JPY ION-TECH CO., LTD. |
| Owner/operator number | 9066119 |
| Product codes | JDI, KWL, KWY, KWZ, LPH, LZO, MAY, MEH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 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, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, MAY - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish, MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3310, 888.3350, 888.3353, 888.3358, 888.3360, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | SHANGHAI JPY ION-TECH CO., LTD. |
| Establishment registrations | 3004748528 |
| FEI numbers | 3004748528 |
| Establishment operations | Contract Sterilizer |
| 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