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 - 10381780001270 Catalog Number : 12-8005

Device Description : Malibu Polyaxial Screw,8.0 x 105mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001287 Catalog Number : 12-8010

Device Description : Malibu Polyaxial Screw,8.0 x 110mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001294 Catalog Number : 12-8030

Device Description : Malibu Polyaxial Screw,8.0 x 30mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001300 Catalog Number : 12-8035

Device Description : Malibu Polyaxial Screw,8.0 x 35mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001317 Catalog Number : 12-8040

Device Description : Malibu Polyaxial Screw,8.0 x 40mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001324 Catalog Number : 12-8045

Device Description : Malibu Polyaxial Screw,8.0 x 45mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001331 Catalog Number : 12-8050

Device Description : Malibu Polyaxial Screw,8.0 x 50mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001348 Catalog Number : 12-8055

Device Description : Malibu Polyaxial Screw,8.0 x 55mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001355 Catalog Number : 12-8060

Device Description : Malibu Polyaxial Screw,8.0 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001362 Catalog Number : 12-8065

Device Description : Malibu Polyaxial Screw,8.0 x 65mm

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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