PREMIA SPINE LTD

Address:Giborey Israel 7,Ramat Poleg, Netanya Central,IL

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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

Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (5) Thoracolumbosacral Pedicle Screw System (NKB) (5)

Premarket Exempt

Clear

ProMIS™ Fixation System - 07290014064997 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x60mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080003 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x70mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080010 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x80mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080027 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x90mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080034 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x100mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080041 Catalog Number :

Device Description : Pre-Bent Rod 6.0x110mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080058 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x120mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : No

Device Count : 1

ProMIS™ Fixation System - 07290014080065 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x130mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080072 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x140mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080089 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x150mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

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