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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (3) Orthopaedic Surgical Planning And Instrument Guides (PBF) (2) Acetabular Cup Orientation System (PLW) (2) System, Image Processing, Radiological (LLZ) (2) Medical Device Data System (OUG) (1) Shoulder Arthroplasty Implantation System (QHE) (1) Shoulder Prosthesis, Reverse Configuration (PHX) (1)

Premarket Exempt

No Yes

Clear

SurgiCase - E314O01030600000110100 Catalog Number : O-01-0-306000-0011-010

Device Description : Femur Osteotomy

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

SurgiCase - E314O01082800000110000 Catalog Number : O-01-0-828000-0011-000

Device Description : Clavicle Osteotomy

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

SurgiCase - E314O0205570000011300 Catalog Number : O-02-0-557000-0011-300

Device Description : Total Hip Arthroplasty

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

SurgiCase - E314O02055700000113000 Catalog Number : O-02-0-557000-0011-300

Device Description : Total Hip Arthroplasty

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

ProPlan CMF - E314PROPLANCMF0 Catalog Number : ProPlan CMF

Device Description : ProPlan CMF

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

ProPlan CMF - E314PROPLANCMFCONNECT0 Catalog Number : ProPlan CMF Connect

Device Description : ProPlan CMF Connect

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

ProPlan CMF - E314PROPLANCMFONLINE0 Catalog Number : ProPlan CMF Online

Device Description : ProPlan CMF Online

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Lima PSI - E314SHCLM010001 Catalog Number : SHC-LM01-00-01

Device Description : Lima CT RSA guide and bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM0100010 Catalog Number : SHC-LM01-00-01

Device Description : Lima CT RSA guide and bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS, QHE, PHX

Prescription Use : Yes

Device Count : 1

Lima PSI - E314SHCLM010101 Catalog Number : SHC-LM01-01-01

Device Description : Lima CT RSA guide

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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