FDA device listing
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3,MAXROM AND +3 HI-WALL
FDA device listing 2063301253 · Zimmer Inc
Key facts
| Proprietary names | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3,MAXROM AND +3 HI-WALL |
|---|---|
| Owner/operator | Zimmer Inc |
| Owner/operator number | 1825034 |
| Premarket submissions | K090103 |
| Product codes | JDI, LPH, LWJ, LZO, MAY, OQG, OQH, OQI |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 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, OQG - Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, OQH - Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented, OQI - Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3350, 888.3353, 888.3358, 888.3360 |
| Review panels | Orthopedic |
| Registered establishments | BIOMET, INC. |
| Establishment registrations | 1825034 |
| FEI numbers | 1825034 |
| 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
- 1–9 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