SpineArt SA

Address:Chemin du Pre-Fleuri 3,Plan-les-Ouates Geneve,CH

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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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No Yes

Clear

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340795 Catalog Number : ELL-PS 06 45-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340801 Catalog Number : ELL-PS 06 50-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340818 Catalog Number : ELL-PS 07 30-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340825 Catalog Number : ELL-PS 07 35-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340832 Catalog Number : ELL-PS 07 40-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340849 Catalog Number : ELL-PS 07 45-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340856 Catalog Number : ELL-PS 07 50-N

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139340863 Catalog Number : ELL-SC 00 00-N

Device Description : SET SCREW

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340870 Catalog Number : ELL-RD 00 30-N

Device Description : Pre-Bent Rod

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ELLIPSE Lumbar posterior osteosynthesis system - 07640139340887 Catalog Number : ELL-RD 00 40-N

Device Description : Pre-Bent Rod

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

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