Materialise NV - FDA 510(k) Cleared Devices

Cleared Nov 20, 2017

Materialise PKA Guide System

K172650 · HSX

Orthopedic · 76d

Cleared Nov 03, 2017

Materialise Glenoid Positioning System

K172054 · KWS

Orthopedic · 120d

Cleared Aug 08, 2017

TruMatch CMF Titanium 3D Printed Implant System

K170272 · JEY

Dental · 190d

Cleared Jun 19, 2017

Materialise Glenoid Positioning System

K170893 · KWS

Orthopedic · 84d

Cleared May 11, 2017

SurgiCase Viewer

K170419 · LLZ

Radiology · 87d

Cleared Jan 18, 2017

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

K163156 · PBF

Orthopedic · 69d

Cleared Nov 07, 2016

Materialise TKA Guide System

K162273 · JWH

Orthopedic · 87d

Cleared Apr 26, 2016

Materialise Glenoid Positioning System

K153602 · KWS

Orthopedic · 131d

Cleared Oct 27, 2015

Acetabular Cup Orientation System

K150780 · PLW

Orthopedic · 216d

Cleared Aug 10, 2015

Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides

K150928 · JWH

Orthopedic · 126d

Cleared May 22, 2014

ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER

K140027 · JWH

Orthopedic · 136d

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 27, 2012

SURGICASE CONNECT

K113599 · LLZ

Radiology · 144d

Cleared Apr 02, 2012

ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS...

K113829 · JWH

Orthopedic · 97d

Cleared Mar 27, 2012

SURGICASE GUIDE

K111558 · HAW

Neurology · 298d

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 Sep 26, 2011

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

K111641 · LLZ

Radiology · 105d

Cleared May 16, 2011

SIGNATURE PLANNER / SIGNATURE GUIDES

K110415 · HRY

Orthopedic · 91d