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

ROMEO posterior osteosynthesis system - 07640139340993 Catalog Number : ELL-RD 02 00-N

Device Description : ROD TITANIUM / STRAIGHT

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341006 Catalog Number : ELL-RD 02 20-N

Device Description : ROD TITANIUM / STRAIGHT

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341013 Catalog Number : ELL-RD 02 40-N

Device Description : ROD TITANIUM / STRAIGHT

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341020 Catalog Number : ELL-RD 03 50-N

Device Description : ROD TITANIUM / STRAIGHT

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341037 Catalog Number : ELL-TR 00 50-N

Device Description : TRANSVERSE ROD

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341044 Catalog Number : ELL-TR 00 60-N

Device Description : TRANSVERSE ROD

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341051 Catalog Number : ELL-TR 00 70-N

Device Description : TRANSVERSE ROD

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341068 Catalog Number : ELL-TR 00 80-N

Device Description : TRANSVERSE ROD

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

ROMEO posterior osteosynthesis system - 07640139341075 Catalog Number : ELL-TC 00 00-N

Device Description : TRANSVERSE CONNECTOR

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 - 07640139341082 Catalog Number : ELL-SS 05 30-N

Device Description : Reduction Screw

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

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