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 - 10381780001171 Catalog Number : 12-7500

Device Description : Malibu Polyaxial Screw,7.5 x 100mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001188 Catalog Number : 12-7505

Device Description : Malibu Polyaxial Screw,7.5 x 105mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001195 Catalog Number : 12-7510

Device Description : Malibu Polyaxial Screw,7.5 x 110mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001201 Catalog Number : 12-7525

Device Description : Malibu Polyaxial Screw,7.5 x 25mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001218 Catalog Number : 12-7565

Device Description : Malibu Polyaxial Screw,7.5 x 65mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001225 Catalog Number : 12-7575

Device Description : Malibu Polyaxial Screw,7.5 x 75mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001232 Catalog Number : 12-7585

Device Description : Malibu Polyaxial Screw,7.5 x 85mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001249 Catalog Number : 12-7590

Device Description : Malibu Polyaxial Screw,7.5 x 90mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001256 Catalog Number : 12-7595

Device Description : Malibu Polyaxial Screw,7.5 x 95mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001263 Catalog Number : 12-8000

Device Description : Malibu Polyaxial Screw,8.0 x 100mm

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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