FDA device listing
Biolox® delta Ceramic Head,Biolox® delta Option Ceramic Head
FDA device listing 1840876580 · EPIONE BIDCO
Key facts
| Proprietary names | Biolox® delta Ceramic Head,Biolox® delta Option Ceramic Head |
|---|---|
| Owner/operator | EPIONE BIDCO |
| Owner/operator number | 10042490 |
| 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 | IONISOS |
| Establishment registrations | 3010178296 |
| FEI numbers | 3003110073 |
| 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