FDA device listing
SignatureTM Guide,SignatureTM Personalized Patient Care System,SignatureTM Planner
FDA device listing 1687131810 · MATERIALISE N.V.
Key facts
| Proprietary names | SignatureTM Guide,SignatureTM Personalized Patient Care System,SignatureTM Planner |
|---|---|
| Owner/operator | MATERIALISE N.V. |
| Owner/operator number | 9029485 |
| Premarket submissions | K111863 |
| Product codes | JDI, KWY, KWZ, LPH, LZO, MAY, MEH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 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, 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 |
| Classification regulations (21 CFR) | 888.3310, 888.3350, 888.3353, 888.3358, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | MATERIALISE N.V., Materialise USA, LLC. |
| Establishment registrations | 3003998208, 3005718816 |
| FEI numbers | 3003998208, 3005718816 |
| 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