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From Health Canada


Manufacturer

MATERIALISE N.V.
Technologielaan 15
Leuven, BE, 3001

Company ID: 134641

Licence No.: 88841

Type: Device Family
Device class: 2
Device first issue date 2012-05-11
Licence name: PROPLAN CMF GUIDES

Device details
Device first issue date Device name Identifier first issue date Device identifier
2012-05-11 PATIENT SPECIFIC GUIDE - CRANIUM, FOREHEAD 2012-05-11 SD900.108
2012-05-11 PATIENT SPECIFIC GUIDE - CRANIUM, FRONTAL BANDEAU 2012-05-11 SD900.109
2012-05-11 PATIENT SPECIFIC GUIDE - CRANIUM, GRAFT 2012-05-11 SD900.110
2012-05-11 PATIENT SPECIFIC GUIDE - DISTRACTOR POSITIONING 2012-05-11 SD900.107
2012-05-11 PATIENT SPECIFIC GUIDE - GRAFT HARVESTING 2012-05-11 SD900.102
2012-05-11 PATIENT SPECIFIC GUIDE - MANDIBLE 2012-05-11 SD900.101
2012-05-11 PATIENT SPECIFIC GUIDE - MIDFACE 2012-05-11 SD900.104
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - BASIC MANDIBLE RECONSTRUCTION 2012-05-11 SD900.003
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - BASIC MIDFACE RECONSTRUCTION 2012-05-11 SD900.056
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - CRANIOFACIAL RECONSTRUCTION WITH MODEL 2012-05-11 SD900.010
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - CRANIOFACIAL RECONSTRUCTION, WITHOUT MODEL 2012-05-11 SD900.011
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - DISTRACTION 2012-05-11 SD900.006
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MANDIBLE RECONSTRUCTION 2012-05-11 SD900.001
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MANDIBLE RECONSTRUCTION, NO MODEL 2012-05-11 SD900.051
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MIDFACE RECON, NO MODEL 2012-05-11 SD900.054
2012-05-11 PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MIDFACE RECONSTRUCTION 2012-05-11 SD900.004
2019-03-11 PATIENT SPECIFIC GUIDE, WITH PLANNING 2019-03-11 SD900.111

Licence No.: 88842

Type: System
Device class: 2
Device first issue date 2012-05-11
Licence name: PROPLAN CMF SOFTWARE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2012-05-11 PROPLAN CMF 2012-05-11 PROPLAN CMF

Licence No.: 93515

Type: Single Device
Device class: 2
Device first issue date 2014-07-04
Licence name: MATERIALISE PERSONALIZED SOLUTIONS OSTEOTOMY GUIDES AND MODELS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2021-06-22 MATERIALISE PERSONALIZED SOLUTIONS OSTEOTOMY GUIDES AND MODELS 2021-06-22 O-00-1-000000-0001-000
2021-06-22 O-00-3-000000-0001-000
2021-06-22 O-01-0-101000-0011-010
2021-06-22 O-01-0-105000-0011-010
2021-06-22 O-01-0-200000-0011-010
2021-06-22 O-01-0-303000-0011-010
2021-06-22 O-01-0-306000-0011-010
2021-06-22 O-01-0-400000-0011-010
2021-06-22 O-01-0-828000-0011-000

Licence No.: 95013

Type: Device Family
Device class: 2
Device first issue date 2015-04-10
Licence name: MIMICS MEDICAL

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-04-10 MIMICS MEDICAL 2015-04-10 MIMICS MEDICAL
2016-03-17 MIMICS INPRINT 2016-03-17 MIMICS INPRINT

Licence No.: 100870

Type: System
Device class: 3
Device first issue date 2018-04-19
Licence name: TRUMATCH CMF TITANIUM 3D PRINTED IMPLANT SYSTEM

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-04-19 TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE 2018-04-19 SD980.104
2018-04-19 TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE 2018-04-19 SD980.014
2018-04-19 SD980.015
2018-04-19 SD980.016
2018-04-19 SD980.017
2018-04-19 SD980.019
2018-04-19 SD980.020
2018-04-19 SD980.021
2018-04-19 TRUMATCH MIDFACE/MANDIBLE - ZYGOMATIC SURGICAL KIT 2018-04-19 SD980.018
2018-04-19 TRUMATCH ORTHOGNATHIC - BIMAXILLARY SURGICAL KIT 2018-04-19 SD980.001
2018-04-19 SD980.002
2018-04-19 SD980.003
2018-04-19 SD980.004
2018-04-19 TRUMATCH ORTHOGNATHIC - GENIOPLASTY SURGICAL KIT 2018-04-19 SD980.013
2018-04-19 TRUMATCH ORTHOGNATHIC - MANDIBULAR SURGICAL KIT 2018-04-19 SD980.009
2018-04-19 SD980.010
2018-04-19 SD980.011
2018-04-19 SD980.012
2018-04-19 TRUMATCH ORTHOGNATHIC - MAXILLARY SURGICAL KIT 2018-04-19 SD980.005
2018-04-19 SD980.006
2018-04-19 SD980.007
2018-04-19 SD980.008
2018-04-19 TRUMATCH TI IMPLANT - ORBITAL 2018-04-19 SD980.103
2019-03-29 TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED ORBITAL KIT 2019-03-29 SD980.110
2019-03-29 SD980.111

Licence No.: 101228

Type: System
Device class: 2
Device first issue date 2018-06-14
Licence name: TRUMATCH PERSONALISED SOLUTIONS SHOULDER SYSTEM

Device details
Device first issue date Device name Identifier first issue date Device identifier
2022-04-04 GUIDE AND BONE MODEL SHOULDER ARTHROPLASTY 2.5MM CENTER PIN 2022-04-04 225503003
2023-06-26 GUIDE AND BONE MODEL SHOULDER ARTHROPLASTY CENTER PIN 2023-06-26 225501003

Licence No.: 101810

Type: System
Device class: 2
Device first issue date 2018-10-03
Licence name: ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (TKA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-10-03 SIGNATURE CUSTOM ALIGNMENT GUIDE (COMPUTED TOMOGRAPHY) 2018-10-03 42-422455
2018-10-03 42-422456
2018-10-03 42-422457
2018-10-03 42-422458
2018-10-03 42-422465
2018-10-03 42-422466
2018-10-03 42-422467
2018-10-03 42-422468
2018-10-03 42-422475
2018-10-03 42-422476
2018-10-03 42-422477
2018-10-03 42-422478
2019-03-05 KNC-ZB02-00-01
2018-10-03 SIGNATURE CUSTOM ALIGNMENT GUIDE (MAGNETIC RESONANCE IMAGING) 2018-10-03 42-422450
2018-10-03 42-422451
2018-10-03 42-422452
2018-10-03 42-422453
2018-10-03 42-422460
2018-10-03 42-422461
2018-10-03 42-422462
2018-10-03 42-422463
2018-10-03 42-422470
2018-10-03 42-422471
2018-10-03 42-422472
2018-10-03 42-422473
2019-03-05 KNM-ZB02-00-01
2018-10-03 SIGNATURE CUT-THROUGH TKA GDE / MDL SET (MAGNETIC RESONANCE IMAGING) 2018-10-03 42-422750
2018-10-03 42-422751
2018-10-03 42-422752
2018-10-03 42-422753
2018-10-03 42-422760
2018-10-03 42-422761
2018-10-03 42-422762
2018-10-03 42-422763
2018-10-03 42-422770
2018-10-03 42-422771
2018-10-03 42-422772
2018-10-03 42-422773
2019-03-05 KNM-ZB05-00-01
2018-10-03 SIGNATURE CUT/THROUGH GUIDE (MAGNETIC RESONANCE IMAGING) 2018-10-03 42-422650
2018-10-03 42-422651
2018-10-03 42-422652
2018-10-03 42-422653
2018-10-03 42-422660
2018-10-03 42-422661
2018-10-03 42-422662
2018-10-03 42-422663
2018-10-03 42-422670
2018-10-03 42-422671
2018-10-03 42-422672
2018-10-03 42-422673
2019-03-05 KNM-ZB06-00-01
2018-10-03 SIGNATURE TKA GDE / MDL SET (COMPUTED TOMOGRAPHY) 2018-10-03 42-422555
2018-10-03 42-422556
2018-10-03 42-422557
2018-10-03 42-422558
2018-10-03 42-422565
2018-10-03 42-422566
2018-10-03 42-422567
2018-10-03 42-422568
2018-10-03 42-422575
2018-10-03 42-422576
2018-10-03 42-422577
2018-10-03 42-422578
2019-03-05 KNC-ZB01-00-01
2018-10-03 SIGNATURE TKA GDE / MDL SET (MAGNETIC RESONANCE IMAGING) 2018-10-03 42-422550
2018-10-03 42-422551
2018-10-03 42-422552
2018-10-03 42-422553
2018-10-03 42-422560
2018-10-03 42-422561
2018-10-03 42-422562
2018-10-03 42-422563
2018-10-03 42-422570
2018-10-03 42-422571
2018-10-03 42-422572
2018-10-03 42-422573
2019-03-05 KNM-ZB01-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (PIN GUIDE AND BONE MODEL - COMPUTED TOMOGRAPHY) 2018-10-03 KNC-ZB03-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (PIN GUIDE AND BONE MODEL - MAGNETIC RESONANCE IMAGING) 2018-10-03 KNM-ZB03-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (PIN GUIDES - FEMUR AND TIBIA - COMPUTED TOMOGRAPHY) 2018-10-03 00-5970-000-15
2018-10-03 00-5970-000-16
2018-10-03 00-5970-000-17
2018-10-03 00-5970-000-18
2018-10-03 00-5970-000-19
2018-10-03 00-5970-000-39
2018-10-03 00-5970-000-42
2018-10-03 00-5970-000-45
2018-10-03 00-5970-000-48
2019-03-05 KNC-ZB04-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (PIN GUIDES - FEMUR AND TIBIA - MAGNETIC RESONANCE IMAGING) 2018-10-03 00-5970-000-01
2018-10-03 00-5970-000-02
2018-10-03 00-5970-000-03
2018-10-03 00-5970-000-13
2018-10-03 00-5970-000-14
2018-10-03 00-5970-000-25
2018-10-03 00-5970-000-29
2018-10-03 00-5970-000-33
2018-10-03 00-5970-000-36
2019-03-05 KNM-ZB04-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (TKA SPRING GUIDE AND BONE MODEL KIT - COMPUTED TOMOGRAPHY) 2018-10-03 KNC-ZB01-00-02
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (TKA SPRING GUIDE KIT - COMPUTED TOMOGRAPHY) 2018-10-03 KNC-ZB02-00-02
2021-08-23 NATURAL KNEE FLEX PIN GUIDE CT SET 2021-08-23 00-5970-000-79
2021-08-23 NATURAL KNEE FLEX PIN GUIDE SET 2021-08-23 00-5970-000-64
2021-08-23 NEXGEN CR PIN GUIDE CT SET 2021-08-23 00-5970-000-73
2021-08-23 NEXGEN CR PIN GUIDE SET 2021-08-23 00-5970-000-58
2021-08-23 NEXGEN CR-FLEX PIN GUIDE CT SET 2021-08-23 00-5970-000-74
2021-08-23 NEXGEN CR-FLEX PIN GUIDE SET 2021-08-23 00-5970-000-59
2021-08-23 NEXGEN CR-FLEX PRI PIN GUIDE CT SET 2021-08-23 00-5970-000-75
2021-08-23 NEXGEN CR-FLEX PRI PIN GUIDE SET 2021-08-23 00-5970-000-60
2021-08-23 NEXGEN CR-FLEX PRI PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-50
2021-08-23 NEXGEN CR-FLEX PRI PIN GUIDES (FEMUR AND TIBIA) CT 2021-08-23 00-5970-000-56
2021-08-23 NEXGEN LPS PIN GUIDE CT SET 2021-08-23 00-5970-000-76
2021-08-23 NEXGEN LPS PIN GUIDE SET 2021-08-23 00-5970-000-61
2021-08-23 NEXGEN LPS-FLEX PIN GUIDE CT SET 2021-08-23 00-5970-000-77
2021-08-23 NEXGEN LPS-FLEX PIN GUIDE SET 2021-08-23 00-5970-000-62
2021-08-23 NEXGEN LPS-FLEX PRI PIN GUIDE CT SET 2021-08-23 00-5970-000-78
2021-08-23 NEXGEN LPS-FLEX PRI PIN GUIDE SET 2021-08-23 00-5970-000-63
2021-08-23 NEXGEN LPS-FLEX PRI PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-51
2021-08-23 NEXGEN LPS-FLEX PRI PIN GUIDES (FEMUR AND TIBIA) CT 2021-08-23 00-5970-000-57
2021-08-23 PERSONA A-REF CR PIN GUIDE CT SET 2021-08-23 00-5970-000-80
2021-08-23 PERSONA A-REF CR PIN GUIDE SET 2021-08-23 00-5970-000-65
2021-08-23 PERSONA A-REF CR TM PIN GUIDE SET 2021-08-23 00-5970-000-69
2021-08-23 PERSONA A-REF PS PIN GUIDE CT SET 2021-08-23 00-5970-000-81
2021-08-23 PERSONA A-REF PS PIN GUIDE SET 2021-08-23 00-5970-000-66
2021-08-23 PERSONA CR TM PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-52
2021-08-23 PERSONA P-REF CR PIN GUIDE CT SET 2021-08-23 00-5970-000-82
2021-08-23 PERSONA P-REF CR PIN GUIDE SET 2021-08-23 00-5970-000-67
2021-08-23 PERSONA P-REF CR TM PIN GUIDE SET 2021-08-23 00-5970-000-71
2021-08-23 PERSONA P-REF PS PIN GUIDE CT SET 2021-08-23 00-5970-000-83
2021-08-23 PERSONA P-REF PS PIN GUIDE SET 2021-08-23 00-5970-000-68
2021-08-23 PERSONA P-REF PS TM PIN GUIDE SET 2021-08-23 00-5970-000-70
2021-08-23 00-5970-000-72
2021-08-23 PERSONATM PREF CR TM PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-54
2021-08-23 PERSONATM PREF PS TM PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-55
2021-08-23 PERSONATM PS TM PIN GUIDES (FEMUR AND TIBIA) 2021-08-23 00-5970-000-53

Licence No.: 101811

Type: System
Device class: 2
Device first issue date 2018-10-03
Licence name: ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (PKA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-10-03 SIGNATURE M PKA GDE/MDL SET 2018-10-03 42-411560
2018-10-03 42-411561
2018-10-03 42-411562
2018-10-03 42-411563
2018-10-03 42-411564
2018-10-03 42-411570
2018-10-03 42-411571
2018-10-03 42-411572
2018-10-03 42-411573
2018-10-03 42-411574
2019-03-06 KNM-ZB11-00-01
2018-10-03 SIGNATURE M PKA GUIDES 2018-10-03 42-411460
2018-10-03 42-411461
2018-10-03 42-411462
2018-10-03 42-411463
2018-10-03 42-411464
2018-10-03 42-411470
2018-10-03 42-411471
2018-10-03 42-411472
2018-10-03 42-411473
2018-10-03 42-411474
2019-03-06 KNM-ZB12-00-01
2018-10-03 ZIMMER BIOMET PATIENT SPECIFIC INSTRUMENTS (GUIDE AND BONE MODEL KIT) 2018-10-03 KNM-ZB13-00-01
2018-10-03 ZIMMER PATIENT SPECIFIC INSTRUMENTS (UNICOMPARTMENTAL HIGH FLEX KNEE - FEMUR AND TIBIA) 2018-10-03 00-5970-000-04
2019-03-06 KNM-ZB14-00-01
2021-11-03 CT SIG SPRING PIN GDE BONE MODEL SET 2021-11-03 42-411475
2021-11-03 CT SIG SPRING PIN GDE SET 2021-11-03 42-411476
2021-11-03 UNICOMPARTMENTAL HI-FLEX SET 2021-11-03 00-5970-000-84

Licence No.: 105919

Type: Device Family
Device class: 2
Device first issue date 2021-03-09
Licence name: PROPLAN CMF ORTHOGNATHIC SPLINTS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2021-03-09 PATIENT SPECIFIC GUIDE - ORTHOGNATHIC, FINAL 2021-03-09 SD900.106
2021-03-09 PATIENT SPECIFIC GUIDE - ORTHOGNATHIC, INTERMEDIATE 2021-03-09 SD900.105
2021-03-09 PATIENT SPECIFIC SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, ONE SPLINT 2021-03-09 SD900.009
2021-03-09 PATIENT SPECIFIC SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS 2021-03-09 SD900.008
2021-03-09 PATIENT SPECIFIC SPLINT, PALATAL 2021-03-09 SD900.114

Licence No.: 111514

Type: System
Device class: 2
Device first issue date 2024-07-16
Licence name: MIMICS ENLIGHT CMF

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-07-16 MIMICS ENLIGHT CMF 2024-07-16 ORTHOGNATHIC PLANNER 6.0
2024-07-16 RECONSTRUCTION PLANNER 6.0

Application information

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