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 Intervertebral Body (KWQ) (9) Appliance, Fixation, Spinal Interlaminal (KWP) (1) Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (1) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

No Yes

Clear

Canaveral® - B1830110000100 Catalog Number : 01-1000-010

Device Description : Modular Polyaxial Headbody

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801400120 Catalog Number : 08-0140-012

Device Description : Self Drilling Variable Screw, 4.0x12mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801400140 Catalog Number : 08-0140-014

Device Description : Self Drilling Variable Screw, 4.0x14mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801400160 Catalog Number : 08-0140-016

Device Description : Self Drilling Variable, 4.0x16mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801400180 Catalog Number : 08-0140-018

Device Description : Self Drilling Variable Screw, 4.0x18mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801400200 Catalog Number : 08-0140-020

Device Description : Self Drilling Variable, 4.0x20mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801450120 Catalog Number : 08-0145-012

Device Description : Self Drilling Rescue Variable Screw, 4.5x12mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801450140 Catalog Number : 08-0145-014

Device Description : Self Drilling Rescue Variable, 4.5x14mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801450160 Catalog Number : 08-0145-016

Device Description : Self Drilling Rescue Variable, 4.5x16mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830801450180 Catalog Number : 08-0145-018

Device Description : Self Drilling Rescue Variable, 4.5x18mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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