FDA 510(k) Applications Submitted by MATERIALISE N.V.

FDA 510(k) Number Submission Date Device Name Applicant
K111863 06/30/2011 SIGNATURE PLANNER,SIGNATURE GUIDES MATERIALISE N.V.
K110415 02/14/2011 SIGNATURE PLANNER / SIGNATURE GUIDES MATERIALISE N.V.
K131559 05/30/2013 MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES MATERIALISE N.V.
K111492 05/31/2011 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS MATERIALISE N.V.
K111558 06/03/2011 SURGICASE GUIDE MATERIALISE N.V.
K121640 06/04/2012 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM MATERIALISE N.V.
K112301 08/10/2011 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MATERIALISE N.V.
K112389 08/18/2011 SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V.
K102795 09/27/2010 SIGNATURE PLANNER; SIGNATURE GUIDES MATERIALISE N.V.
K103136 10/25/2010 SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V.
K113599 12/05/2011 SURGICASE CONNECT MATERIALISE N.V.
K113829 12/27/2011 ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE MATERIALISE N.V.
K060950 04/06/2006 3MATIC MATERIALISE N.V.
K033849 12/11/2003 SIMPLANT SYSTEM MATERIALISE N.V.
K053592 12/23/2005 SIMPLANT DR. JAMES MATERIALISE N.V.
K251554 05/21/2025 Materialise TKA Guide System Materialise N.V.
K233408 10/06/2023 Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise N.V.
K093533 11/16/2009 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 MATERIALISE N.V.
K091263 04/30/2009 ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) MATERIALISE N.V.
K150928 04/06/2015 Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides MATERIALISE N.V.
K241143 04/25/2024 Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise N.V.
K242813 09/18/2024 Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise N.V.
K970617 02/18/1997 CT-MODELLER SYSTEM MATERIALISE N.V.
K190874 04/04/2019 Materialise Mimics Enlight Materialise N.V.
K073449 12/10/2007 SURGICASE MATERIALISE N.V.
K073468 12/10/2007 MIMICS MATERIALISE N.V.
K140027 01/06/2014 ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER MATERIALISE N.V.
K140257 02/03/2014 SIGNATURE PLANNER, SIGNATURE GUIDES MATERIALISE N.V.
K111641 06/13/2011 SURGICASE ORTHOGNATHIC SOFTWARE WIZARD MATERIALISE N.V.
K132290 07/23/2013 SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES MATERIALISE N.V.
K133162 10/17/2013 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA MATERIALISE N.V.
K233217 09/28/2023 Mimics Cardiac Planner Materialise N.V.


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