FDA device listing
AtlasPlan Shoulder System,Lima Personalized Surgical Instruments,Match Point System,Match Point System…
FDA device listing 1468238354 · MATERIALISE N.V.
Key facts
| Proprietary names | AtlasPlan Shoulder System,Lima Personalized Surgical Instruments,Match Point System,Match Point System guides,Materialise Glenoid Positioning System,Materialise Glenoid Positioning System guides,Materialise Shoulder Guide and Models,Materialise Shoulder Planner,Materialise Shoulder System,Materialise SurgiCase Planner,SurgiCase Planner,SurgiCase Shoulder Planner,TruMatch Personalized Solutions… |
|---|---|
| Owner/operator | MATERIALISE N.V. |
| Owner/operator number | 9029485 |
| Premarket submissions | K230315 |
| Product codes | KWS, PHS, QHE |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, PHS - Oral Airway Assist, QHE - Shoulder Arthroplasty Implantation System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 868.5110, 888.3660 |
| Review panels | Anesthesiology, Orthopedic |
| Registered establishments | MATERIALISE N.V., Materialise Sdn Bhd, Materialise Ukraine, Rep. office, Materialise USA, LLC. |
| Establishment registrations | 3003998208, 3005718816, 3009555440, 3009555447 |
| FEI numbers | 3003998208, 3005718816, 3009555440, 3009555447 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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