Seaspine, Inc.

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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) 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

UCR - 10381780000662 Catalog Number : 10-4740

Device Description : Polyaxial Screw 4.75 x 40 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

UCR - 10381780000679 Catalog Number : 10-4745

Device Description : Polyaxial Screw 4.75 x 45 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000686 Catalog Number : 10-4750

Device Description : Polyaxial Screw 4.75 x 50 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

UCR - 10381780000693 Catalog Number : 10-4755

Device Description : Polyaxial Screw 4.75 x 55 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000709 Catalog Number : 10-6025

Device Description : Polyaxial Screw 6.0 x 25 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

UCR - 10381780000716 Catalog Number : 10-6030

Device Description : Polyaxial Screw 6.0 x 30 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000723 Catalog Number : 10-8030

Device Description : Polyaxial Screw 8.0 x 30 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000730 Catalog Number : 11-4725

Device Description : Polyaxial Reduction Screw 4.75 x 25 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

UCR - 10381780000747 Catalog Number : 11-4730

Device Description : Polyaxial Reduction Screw 4.75 x 30 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000754 Catalog Number : 11-4735

Device Description : Polyaxial Reduction Screw 4.75 x 35 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

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