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) (10)

Premarket Exempt

No Yes

Clear

Panama™ - B1830804450200 Catalog Number : 08-0445-020

Device Description : Self Tapping Rescue Fixed Screw, 4.5x20mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805400120 Catalog Number : 08-0540-012

Device Description : Self Drilling Bicortical Variable Screw, 4.0x12mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805400140 Catalog Number : 08-0540-014

Device Description : Self Drilling Bicortical Variable Screw, 4.0x14mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805400160 Catalog Number : 08-0540-016

Device Description : Self Drilling Bicortical Variable Screw, 4.0x16mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805400180 Catalog Number : 08-0540-018

Device Description : Self Drilling Bicortical Variable Screw, 4.0x18mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805400200 Catalog Number : 08-0540-020

Device Description : Self Drilling Bicortical Variable Screw, 4.0x20mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805450120 Catalog Number : 08-0545-012

Device Description : Self Drilling Rescue Bicortical Variable Screw, 4.5x12mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805450140 Catalog Number : 08-0545-014

Device Description : Self Drilling Rescue Bicortical Variable Screw, 4.5x14mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805450160 Catalog Number : 08-0445-016

Device Description : Self Drilling Rescue Bicortical Variable Screw, 4.5x16mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Panama™ - B1830805450180 Catalog Number : 08-0545-018

Device Description : Self Drilling Rescue Bicortical Variable Screw, 4.5x18mm

Device Class : 2

Duns Number: 042993143

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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