FDA device listing
TAPERLOC COMPLETE, SIZE 5 AND 6
FDA device listing 1655424436 · Zimmer Inc
Key facts
| Proprietary names | TAPERLOC COMPLETE, SIZE 5 AND 6 |
|---|---|
| Owner/operator | Zimmer Inc |
| Owner/operator number | 1825034 |
| Premarket submissions | K103755 |
| Product codes | JDI, JDL, KWA, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MEH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, JDL - Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), KWA - Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 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, 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, Class III |
| Classification regulations (21 CFR) | 888.3310, 888.3320, 888.3330, 888.3350, 888.3353, 888.3358, 888.3360, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | BIOMET, INC., Changzhou Biomet Medical Devices Co., Ltd., Zhejiang Biomet Medical Products Co., Ltd. |
| Establishment registrations | 1825034, 3006801265, 3007923096 |
| FEI numbers | 1825034, 3006801265, 3007923096 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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