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 - 10381780000969 Catalog Number : 12-4560

Device Description : Malibu Polyaxial Screw, 4.5 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780000976 Catalog Number : 12-5025

Device Description : Malibu Polyaxial Screw, 5.0 x 25mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780000983 Catalog Number : 12-5030

Device Description : Malibu Polyaxial Screw, 5.0 x 30mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780000990 Catalog Number : 12-5035

Device Description : Malibu Polyaxial Screw, 5.0 x 35mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001003 Catalog Number : 12-5040

Device Description : Malibu Polyaxial Screw, 5.0 x 40mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001010 Catalog Number : 12-5045

Device Description : Malibu Polyaxial Screw,5.0 x 45mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001027 Catalog Number : 12-5050

Device Description : Malibu Polyaxial Screw,5.0 x 50mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001034 Catalog Number : 12-5055

Device Description : Malibu Polyaxial Screw,5.0 x 55mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNH, KWP, NKB, MNI

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001041 Catalog Number : 12-5060

Device Description : Malibu Polyaxial Screw,5.0 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

Malibu - 10381780001065 Catalog Number : 12-5560

Device Description : Malibu Polyaxial Screw,5.5 x 60mm

Device Class : 2

Duns Number: 119614407

Premarket Exempt : No

Product Code : MNI, NKB, KWP, MNH

Prescription Use : Yes

Device Count : 1

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