FDA device listing
Evolve AP Cup
FDA device listing 1347110703 · Signature Orthopaedics Pty Limited
Key facts
| Proprietary names | Evolve AP Cup |
|---|---|
| Owner/operator | Signature Orthopaedics Pty Limited |
| Owner/operator number | 10037793 |
| Premarket submissions | K252824 |
| Product codes | JDI, KWZ, LPH, MEH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 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 |
| Review panels | Orthopedic |
| Registered establishments | Signature Orthopaedics Europe Ltd, SIGNATURE ORTHOPAEDICS PTY LIMITED |
| Establishment registrations | 3008262872, 3014763043 |
| FEI numbers | 3008262872, 3014763043 |
| 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