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 - 10381780000860 Catalog Number : 11-6050

Device Description : Polyaxial Reduction Screw 6.0 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 - 10381780000877 Catalog Number : 11-6055

Device Description : Polyaxial Reduction Screw 6.0 x 55 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, MNH, NKB, KWP

Prescription Use : Yes

Device Count : 1

UCR - 10381780000884 Catalog Number : 11-6060

Device Description : Polyaxial Reduction Screw 6.0 x 60 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

UCR - 10381780000891 Catalog Number : 11-6730

Device Description : Polyaxial Reduction Screw 6.75 x 30 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, MNH, NKB, KWP

Prescription Use : Yes

Device Count : 1

UCR - 10381780000907 Catalog Number : 11-6760

Device Description : Polyaxial Reduction Screw 6.75 x 60 mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, NKB, MNI, KWP

Prescription Use : Yes

Device Count : 1

UCR - 10381780000914 Catalog Number : 11-8030

Device Description : Polyaxial Reduction Screw 8.0 x 30mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

UCR - 10381780000921 Catalog Number : 11-8035

Device Description : Polyaxial Reduction Screw 8.0 x 35mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, NKB, MNI, KWP

Prescription Use : Yes

Device Count : 1

UCR - 10381780000938 Catalog Number : 11-8055

Device Description : Polyaxial Reduction Screw 8.0 x 55mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : KWP, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

UCR - 10381780000945 Catalog Number : 11-8060

Device Description : Polyaxial Reduction Screw 8.0 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, NKB, MNI, KWP

Prescription Use : Yes

Device Count : 1

Malibu - 10381780000952 Catalog Number : 12-4555

Device Description : Malibu Polyaxial Screw, 4.5 x 55mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

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