Materialise NV

Address:15 TECHNOLOGIELAAN,LEUVEN Vlaams Brabant,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (6) Knee Arthroplasty Implantation System (OOG) (2) Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (HSX) (2) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH) (2) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (2) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (2)

Premarket Exempt

No Yes

Clear

VISIONAIRE UNI - 00885556700167 Catalog Number : V0500001

Device Description : NONSTERILE VISIONAIRE UNI CUTTING GUIDE

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

VISIONAIRE UNI - 00885556700204 Catalog Number : V0500002

Device Description : NONSTERILE VISIONAIRE UNI BONE MODEL

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

Mimics Plugin - 05404028000120 Catalog Number : Segment Thin Bone

Device Description : Mimics Plugin Segment Thin Bone

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Mimics Plugin - 05404028000137 Catalog Number : Compare Masks

Device Description : Mimics Plugin Compare Masks

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Mimics Automatic Algorithms - 05404028000342 Catalog Number : All Bones CT

Device Description : Mimics Automatic Algorithms All Bones CT

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Mimics Automatic Algorithms - 05404028000366 Catalog Number : CMF CBCT

Device Description : Mimics Automatic Algorithms CMF CBCT

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Mimics Automatic Algorithms - 05404028000373 Catalog Number : Shoulder CT

Device Description : Mimics Automatic Algorithms Shoulder CT

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Mimics Automatic Algorithms - 05404028000380 Catalog Number : Hip CT

Device Description : Mimics Automatic Algorithms Hip CT

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Zimmer Biomet Patient Specific Instruments - 05420060310010 Catalog Number : KNM-ZB01-00-01

Device Description : ZB MRI TKA Biomet Pin Guide and Bone Model kit

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : OOG, OIY, MBH, JWH

Prescription Use : Yes

Device Count : 1

Zimmer Biomet Patient Specific Instruments - 05420060310027 Catalog Number : KNM-ZB02-00-01

Device Description : ZB MRI TKA Biomet Pin Guide kit

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

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