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The Materialise Group

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Web: http://www.materialise.com
E-Mail:
Address: Technologielaan 15, 3001 Leuven, Belgium
Phone: +32-(16)-39 66 11 | Fax: +32-(16)-39 66 00 | Map/Directions >>
 
 

Profile: The Materialise Group is engaged in the field of rapid industrial and medical prototyping. Our medical solutions include 3-matic, simplant, safe system, surgicase CMF, surgicase orthopaedics and medical models. Our surgicase orthopaedics is user-friendly CT-based software for planning orthopaedic interventions. Our Materialise rapid shell modeling software digitizes the entire design and production process of hearing aids.

FDA Registration Number: 3003998208
US Agent: Jenny Jones / Materialise Usa Llc.
Phone: +1-(734)-259-7017  Fax: +1-(734)-662-7891  E-Mail:

19 Products/Services (Click for related suppliers)  
• Dental Devices
• Dental Solution, Stereolithographic Models
• Imaging Software
• Medical Imaging
• Medical Imaging Products
• Medical Imaging Software
• Medical Imaging Software for 3D Modeling
• Medical Imaging Systems
• Medical Management Software
• Medical Software Solutions
• Medical Solution, Rapid Shell Modeling
• Medical Solution, SimPlant 3D Planning Software
• Medical Solution, SurgiCase Orthopaedics
• Patellofemorotibial Knee Prosthesis (FDA Code: MBH / 888.3565)
A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.
• Radiological Image Processing System (FDA Code: LLZ / 892.2050)
A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
• Rapid Prototype Models for Medical Applications - Surgical Planning and Simulation
• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560)
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
• Software Services
• Templates (FDA Code: HWT / 888.4800)
A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

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