Flow-FX

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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

Rod, Fixation, Intramedullary And Accessories (HSB) (10)

Premarket Exempt

No Yes

Clear

Flow-Nail™ - B2671010040650 Catalog Number : 101CSCR-105-065TI

Device Description : SCREW, CORTICAL (65 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010040700 Catalog Number : 101CSCR-105-070TI

Device Description : SCREW, CORTICAL (70 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010040750 Catalog Number : 101CSCR-105-075TI

Device Description : SCREW, CORTICAL (75 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010040800 Catalog Number : 101CSCR-105-080TI

Device Description : SCREW, CORTICAL (80 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060000 Catalog Number : 101ARSC-050-050TI

Device Description : SCREW, ANTI-ROTATION (50 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060010 Catalog Number : 101ARSC-050-060TI

Device Description : SCREW, ANTI-ROTATION (60 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060020 Catalog Number : 101ARSC-050-070TI

Device Description : SCREW, ANTI-ROTATION (70 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060030 Catalog Number : 101ARSC-050-080TI

Device Description : SCREW, ANTI-ROTATION (80 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060040 Catalog Number : 101ARSC-050-090TI

Device Description : SCREW, ANTI-ROTATION (90 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flow-Nail™ - B2671010060050 Catalog Number : 101ARSC-050-100TI

Device Description : SCREW, ANTI-ROTATION (100 MM)

Device Class : 2

Duns Number: 079293587

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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