Medical Device Manufacturer · BE , Leuven

Materialise NV - FDA 510(k) Cleared Devices

61 submissions · 61 cleared · Since 1997
61
Total
61
Cleared
0
Denied
39 devices
26-39 of 39
Cleared Apr 10, 2014
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
K132290 · PBF
Orthopedic · 261d
Cleared Apr 02, 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · MBH
Orthopedic · 58d
Cleared Feb 25, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC...
K133162 · JWH
Orthopedic · 131d
Cleared Sep 27, 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · KWS
Orthopedic · 120d
Cleared Dec 05, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
K121640 · JWH
Orthopedic · 184d
Cleared Jul 20, 2012
SURGICASE CONNECT, SURGICASE GUIDE
K112389 · PBF
Orthopedic · 337d
Cleared Jun 15, 2012
SIGNATURE PLANNER,SIGNATURE GUIDES
K111863 · JDI
Orthopedic · 351d
Cleared Apr 02, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K113829 · JWH
Orthopedic · 97d
Cleared Jan 06, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
K112301 · HSX
Orthopedic · 149d
Cleared Oct 13, 2011
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT...
K111492 · JWH
Orthopedic · 135d
Cleared May 16, 2011
SIGNATURE PLANNER / SIGNATURE GUIDES
K110415 · HRY
Orthopedic · 91d
Cleared Feb 02, 2011
SIGNATURE PLANNER
K102795 · JWH
Orthopedic · 128d
Cleared Feb 17, 2010
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
K093533 · MBH
Orthopedic · 93d
Cleared Nov 19, 2009
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K091263 · JWH
Orthopedic · 203d
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