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) (4) Orthosis, Spinal Pedicle Fixation (MNI) (4) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (4)

Premarket Exempt

No Yes

Clear

Canaveral® - B183180000100 Catalog Number : 01-7000-010

Device Description : 5.5mm Rod Caddy

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Canaveral® - B183180040010 Catalog Number : 01-7000-011

Device Description : Base, Deformity Implant Case 1

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Canaveral® - B183180040020 Catalog Number : 01-7000-012

Device Description : Tray, Deformity Implant Case 1

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Canaveral® - B183180050010 Catalog Number : 01-7000-001

Device Description : Generic Instrument Tray

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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