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

Medical Device Data System (OUG) (2) Orthopaedic Surgical Planning And Instrument Guides (PBF) (1) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer (MBV) (1) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH) (1) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (1) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (1) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (1) System, Image Processing, Radiological (LLZ) (1) Knee Arthroplasty Implantation System (OOG) (1) Template (HWT) (1)

Premarket Exempt

No Yes

Clear

SurgiCase Planner - E314SURGICASESHOULPLAN0 Catalog Number : SurgiCase Shoulder Planner

Device Description : SurgiCase Shoulder Planner

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : No

Device Count : 1

SurgiCase Transfer - E314SURGICASETRANSFER0 Catalog Number : SurgiCase Transfer

Device Description : SurgiCase Transfer

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

SurgiCase Viewer - E314SURGICASEVIEWER0 Catalog Number : SurgiCase Viewer

Device Description : SurgiCase Viewer

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

SurgiCase - E314UEAMA0100010 Catalog Number : UEA-MA01-00-01

Device Description : Radius/ulna osteotomy, Pediatric

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

SurgiCase - E314UEAMA1000010 Catalog Number : UEA-MA10-00-01

Device Description : Anatomical model, Pediatric

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Zimmer - E314ZIMMERPSIOMS0 Catalog Number : Zimmer online management system

Device Description : Zimmer online management system

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Zimmer - E314ZIMMERPSIP0 Catalog Number : Zimmer PSIP

Device Description : Zimmer PSIP

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : MBV, JWH, MBH, OIY, OOG

Prescription Use : No

Device Count : 1

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