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

Knee Arthroplasty Implantation System (OOG) (4) Plate, Bone (JEY) (4) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH) (4) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (4) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (4) System, Image Processing, Radiological (LLZ) (2)

Premarket Exempt

No Yes

Clear

Zimmer Biomet Patient Specific Instruments - 05420060310133 Catalog Number : KNC-ZB03-00-01

Device Description : ZB CT TKA Zimmer Pin Guide and Bone Model kit

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Zimmer Biomet Patient Specific Instruments - 05420060310140 Catalog Number : KNC-ZB04-00-01

Device Description : ZB CT TKA Zimmer Pin Guide kit

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Zimmer Biomet Patient Specific Instruments - 05420060310430 Catalog Number : KNC-ZB01-00-02

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

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Zimmer Biomet Patient Specific Instruments - 05420060310461 Catalog Number : KNC-ZB02-00-02

Device Description : ZB CT TKA Biomet Spring Pin Guide kit

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

HeartPrint - 05420060346002 Catalog Number : HEAPR-01-002-01

Device Description : Heartprint medical model, SLA

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

HeartPrint - 05420060346019 Catalog Number : HEAPR-01-001-01

Device Description : Heartprint medical model, SLS

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350016 Catalog Number : SD900.001

Device Description : Patient Specific Instrument and Planning Kit, Mandible Reconstruction

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350030 Catalog Number : SD900.003

Device Description : Patient Specific Instrument and Planning Kit, Basic Mandible Reconstruction

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350047 Catalog Number : SD900.004

Device Description : Patient Specific Instrument and Planning Kit, Midface Reconstruction

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

ProPlan CMF - 05420060350061 Catalog Number : SD900.006

Device Description : Patient Specific Instrument and Planning Kit, Distraction

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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