Materialise NV

Materialise NV — FDA 510(k) Submissions

Materialise NV has submitted 60 FDA 510(k) premarket notifications since 1997, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Processing, Radiological, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Shoulder Arthroplasty Implantation System, Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented, Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer . Use the specialty filter in the sidebar to narrow results.