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

Malibu - 10381780001072 Catalog Number : 12-6060

Device Description : Malibu Polyaxial Screw,6.0 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001089 Catalog Number : 12-6500

Device Description : Malibu Polyaxial Screw,6.5 x 100mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001096 Catalog Number : 12-6505

Device Description : Malibu Polyaxial Screw,6.5 x 105mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001102 Catalog Number : 12-6510

Device Description : Malibu Polyaxial Screw,6.5 x 110mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001119 Catalog Number : 12-6575

Device Description : Malibu Polyaxial Screw,6.5 x 75mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001126 Catalog Number : 12-6580

Device Description : Malibu Polyaxial Screw,6.5 x 80mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001133 Catalog Number : 12-6585

Device Description : Malibu Polyaxial Screw,6.5 x 85mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001140 Catalog Number : 12-6590

Device Description : Malibu Polyaxial Screw,6.5 x 90mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001157 Catalog Number : 12-6595

Device Description : Malibu Polyaxial Screw,6.5 x 95mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001164 Catalog Number : 12-7025

Device Description : Malibu Polyaxial Screw,7.0 x 25mm

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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