MATERIALISE USA, L.L.C.

Address:44650 Helm Court,Plymouth,MI,48170,US

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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

Acetabular Cup Orientation System (PLW) (6) Knee Arthroplasty Implantation System (OOG) (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)

Premarket Exempt

Clear

Bespoke - E314HPCCO010001 Catalog Number : HPC-CO01-00-01

Device Description : Consensus CT THA guides and bone models

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314HPCCO0100010 Catalog Number : HPC-CO01-00-01

Device Description : Consensus CT THA guides and bone models

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314HPCCO010101 Catalog Number : HPC-CO01-01-01

Device Description : Consensus CT THA hip guide

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314HPCCO0101010 Catalog Number : HPC-CO01-01-01

Device Description : Consensus CT THA hip guide

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314HPCCO010201 Catalog Number : HPC-CO01-02-01

Device Description : Consensus CT THA hip bone model

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314HPCCO0102010 Catalog Number : HPC-CO01-02-01

Device Description : Consensus CT THA hip bone model

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : PLW

Prescription Use : Yes

Device Count : 1

Bespoke - E314KNMCO010001 Catalog Number : KNM-CO01-00-01

Device Description : Consensus MRI TKA guides and bone models

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : OOG, OIY, MBH, JWH

Prescription Use : Yes

Device Count : 1

Bespoke - E314KNMCO0100010 Catalog Number : KNM-CO01-00-01

Device Description : Consensus MRI TKA guides and bone models

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Bespoke - E314KNMCO010101 Catalog Number : KNM-CO01-01-01

Device Description : Consensus MRI TKA femur guide

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Bespoke - E314KNMCO0101010 Catalog Number : KNM-CO01-01-01

Device Description : Consensus MRI TKA femur guide

Device Class : 2

Duns Number: 946657160

Premarket Exempt : No

Product Code : OOG, OIY, MBH, JWH

Prescription Use : Yes

Device Count : 1

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