FDA device listing
DXTEND CTA HEAD,DXTEND GLENOSPHERE,DXTEND HUMERAL SPACER,DXTEND IMP HUM CIM,DXTEND MBLOC HUM EPI,DXTEND METAGLENE,DXTEND…
FDA device listing 1717326541 · EPIONE BIDCO
Key facts
| Proprietary names | DXTEND CTA HEAD,DXTEND GLENOSPHERE,DXTEND HUMERAL SPACER,DXTEND IMP HUM CIM,DXTEND MBLOC HUM EPI,DXTEND METAGLENE,DXTEND RETENT PE CUP,DXTEND SCREW LOCK,DXTEND SCREW NO LOCK,DXTEND STAND PE CUP |
|---|---|
| Owner/operator | EPIONE BIDCO |
| Owner/operator number | 10042490 |
| Product codes | HSD, KWS |
| Device names | HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660, 888.3690 |
| Review panels | Orthopedic |
| Registered establishments | IONISOS |
| Establishment registrations | 3002807295, 3010178296 |
| FEI numbers | 3002807295, 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