Seaspine, Inc.

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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, For Degenerative Disc Disease (NKB) (10) Orthosis, Spinal Pedicle Fixation (MNI) (8) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (8)

Premarket Exempt

No Yes

Clear

Newport - 10381780031413 Catalog Number : 61-7565

Device Description : NewPort Double Lead Screw, DIA 7.5 x 65mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031420 Catalog Number : 61-7570

Device Description : NewPort Double Lead Screw, DIA 7.5 x 70mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031437 Catalog Number : 61-7575

Device Description : NewPort Double Lead Screw, DIA 7.5 x 75mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031444 Catalog Number : 61-7580

Device Description : NewPort Double Lead Screw, DIA 7.5 x 80mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031451 Catalog Number : 61-7585

Device Description : NewPort Double Lead Screw, DIA 7.5 x 85mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031468 Catalog Number : 61-7590

Device Description : NewPort Double Lead Screw, DIA 7.5 x 90mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Newport - 10381780031475 Catalog Number : 61-7595

Device Description : NewPort Double Lead Screw, DIA 7.5 x 95mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031482 Catalog Number : 62-5540

Device Description : Cannulated Reduction Polyaxial Screw, Ø5.5 x 40mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

Malibu™ - 10381780031598 Catalog Number : MLB8IMP

Device Description : Malibu 8.0 Implant

Device Class : 2

Duns Number: 119614407

Premarket Exempt : Yes

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Malibu™ - 10381780031604 Catalog Number : MLBDFIMP

Device Description : Malibu Deformity Implant

Device Class : 2

Duns Number: 119614407

Premarket Exempt : Yes

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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