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FDA 510(k) Applications Submitted by Oliver Clemens
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140027
01/06/2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
MATERIALISE N.V.
K140257
02/03/2014
SIGNATURE PLANNER, SIGNATURE GUIDES
MATERIALISE N.V.
K170419
02/13/2017
SurgiCase Viewer
Materialise NV
K150780
03/25/2015
Acetabular Cup Orientation System
MATERIALISE NV
K170893
03/27/2017
Materialise Glenoid Positioning System
Materialise NV
K111641
06/13/2011
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
MATERIALISE N.V.
K172054
07/06/2017
Materialise Glenoid Positioning System
Materialise NV
K132290
07/23/2013
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
MATERIALISE N.V.
K162273
08/12/2016
Materialise TKA Guide System
MATERIALISE NV
K172650
09/05/2017
Materialise PKA Guide System
Materialise NV
K133162
10/17/2013
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
MATERIALISE N.V.
K173445
11/06/2017
Materialise TKA Guide System
Materialise NV
K163156
11/10/2016
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
Materialise NV
K173619
11/22/2017
Mimics inPrint
Materialise NV
K153602
12/17/2015
Materialise Glenoid Positioning System
MATERIALISE NV
K173970
12/29/2017
Materialise PKA Guide System
Materialise NV
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