FLOSPINE LLC

Address:3651 FAU Blvd,Boca Raton,FL,33431,US

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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) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (10)

Premarket Exempt

No Yes

Clear

Canaveral® - B183171000260 Catalog Number : 01-7000-026

Device Description : Reduction Crown

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWP, NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000270 Catalog Number : 01-7000-027

Device Description : Closed Polyaxial Screwdriver, Short

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB, KWP

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000280 Catalog Number : 01-7000-028

Device Description : Headbody Manipulator

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWP, NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000290 Catalog Number : 01-7000-029

Device Description : Coronal Bender 5.5mm, Left

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB, KWP

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000300 Catalog Number : 01-7000-030

Device Description : Coronal Bender 5.5mm, Right

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWP, NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000310 Catalog Number : 01-7000-031

Device Description : In-Situ Bender 5.5mm, Left

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB, KWP

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000320 Catalog Number : 01-7000-032

Device Description : In-Situ Bender 5.5mm, Right

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWP, NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000330 Catalog Number : 01-7000-033

Device Description : Ratcheting Box Wrench

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB, KWP

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000340 Catalog Number : 01-7000-034

Device Description : Hood Driver - Final Tightening

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWP, NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

Canaveral® - B183171000350 Catalog Number : 01-7000-035

Device Description : Palm Handle, Hood Driver

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB, KWP

Prescription Use : Yes

Device Count : 1

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