NEUROSTRUCTURES, INC

Address:4300 Sigma Road,Dallas,TX,75244,US

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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 Intervertebral Body (KWQ) (6) Appliance, Fixation, Spinal Interlaminal (KWP) (4) Orthosis, Spinal Pedicle Fixation (MNI) (4) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4)

Premarket Exempt

Clear

Palladian™ - 00841508107149 Catalog Number :

Device Description : Straight Lenke Probe

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWP, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Palladian™ - 00841508107156 Catalog Number :

Device Description : Raised Seat Screw Driver with Handle

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : NKB, MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

Palladian™ - 00841508107163 Catalog Number :

Device Description : Holmed Rod Template

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : NKB, MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

Palladian™ - 00841508107170 Catalog Number :

Device Description : Off Center Torque Handle

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWP, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107187 Catalog Number :

Device Description : Adjustable Plate Assembly , 36mm-40mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107194 Catalog Number :

Device Description : 5.5mm Cortical Bone Screw 30mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107200 Catalog Number :

Device Description : 5.5mm Cortical Bone Screw 35mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107217 Catalog Number :

Device Description : 5.5mm Cortical Bone Screw 40mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107224 Catalog Number :

Device Description : 5.5mm Cortical Bone Screw 45mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Belvedere™ - 00841508107231 Catalog Number :

Device Description : 5.5mm Cortical Bone Screw 50mm

Device Class : 2

Duns Number: 079391677

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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