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. |
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. |
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. |
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