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) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

Polyaxial Pedicle Screw - 07290014080478 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x45 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080485 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x50 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080492 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x55 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080683 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.7.5x35 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080799 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.6.5x25 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080805 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.6.5x30 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080812 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.7.5x25 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Polyaxial Pedicle Screw - 07290014080829 Catalog Number :

Device Description : Poly. Pedicle Screw Cann.,Torx SS, Gr.7.5x30 mm

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

ProMIS™ Fixation System - 07290014381018 Catalog Number :

Device Description : Straight Rod Ø6.0x250mm 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 - 07290014381025 Catalog Number :

Device Description : Straight Rod Ø6.0x300mm Hex Edge

Device Class : 2

Duns Number: 649220779

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : No

Device Count : 1

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