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 - 10381780000761 Catalog Number : 11-4740

Device Description : Polyaxial Reduction Screw 4.75 x 40 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000778 Catalog Number : 11-4745

Device Description : Polyaxial Reduction Screw 4.75 x 45 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

UCR - 10381780000785 Catalog Number : 11-4750

Device Description : Polyaxial Reduction Screw 4.75 x 50 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000792 Catalog Number : 11-4755

Device Description : Polyaxial Reduction Screw 4.75 x 55 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

UCR - 10381780000808 Catalog Number : 11-5555

Device Description : Polyaxial Reduction Screw 5.5 x 55 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000815 Catalog Number : 11-6025

Device Description : Polyaxial Reduction 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 - 10381780000822 Catalog Number : 11-6030

Device Description : Polyaxial Reduction 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 - 10381780000839 Catalog Number : 11-6035

Device Description : Polyaxial Reduction Screw 6.0 x 35 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

UCR - 10381780000846 Catalog Number : 11-6040

Device Description : Polyaxial Reduction Screw 6.0 x 40 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : NKB, MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

UCR - 10381780000853 Catalog Number : 11-6045

Device Description : Polyaxial Reduction Screw 6.0 x 45 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, MNH, NKB, KWP

Prescription Use : Yes

Device Count : 1

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