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

Polyaxial Pedicle Screw - 07290014080157 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.6.5x35 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014080263 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x45mm 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 - 07290014080270 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x55mm 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 - 07290014080287 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x65mm 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 - 07290014080294 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x75mm 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 - 07290014080324 Catalog Number :

Device Description : Pre-Bent Rod Ø6.0x35mm R128 Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080430 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x25 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080447 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x30 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080454 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x35 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080461 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x40 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

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