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

Premarket Exempt

No Yes

Clear

Newport - 10381780031314 Catalog Number : 61-7500

Device Description : NewPort Double Lead Screw, DIA 7.5 x 100mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031321 Catalog Number : 61-7505

Device Description : NewPort Double Lead Screw, DIA 7.5 x 105mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031338 Catalog Number : 61-7510

Device Description : NewPort Double Lead Screw, DIA 7.5 x 110mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031345 Catalog Number : 61-7530

Device Description : NewPort Double Lead Screw, DIA 7.5 x 30mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031352 Catalog Number : 61-7535

Device Description : NewPort Double Lead Screw, DIA 7.5 x 35mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031369 Catalog Number : 61-7540

Device Description : NewPort Double Lead Screw, DIA 7.5 x 40mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031376 Catalog Number : 61-7545

Device Description : NewPort Double Lead Screw, DIA 7.5 x 45mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031383 Catalog Number : 61-7550

Device Description : NewPort Double Lead Screw, DIA 7.5 x 50mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Newport - 10381780031390 Catalog Number : 61-7555

Device Description : NewPort Double Lead Screw, DIA 7.5 x 55mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Newport - 10381780031406 Catalog Number : 61-7560

Device Description : NewPort Double Lead Screw, DIA 7.5 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

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