VILEX IN TENNESSEE, INC.

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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, Nail/Blade/Plate Combination, Multiple Component (KTT) (10)

Premarket Exempt

Yes No

Clear

STATIX - 00841731110053 Catalog Number :

Device Description : Ring, Statix 5/8 140mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110060 Catalog Number :

Device Description : Ring, Statix 5/8 160mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110077 Catalog Number :

Device Description : Ring, Statix 5/8 180mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110084 Catalog Number :

Device Description : Ring, Statix 5/8 210mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110091 Catalog Number :

Device Description : Ring, Statix Full 140mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110107 Catalog Number :

Device Description : Ring, Statix Full 160mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110114 Catalog Number :

Device Description : Ring, Statix Full 180mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110121 Catalog Number :

Device Description : Ring, Statix Full 210mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110138 Catalog Number :

Device Description : FootPlate, Statix 140mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110145 Catalog Number :

Device Description : FootPlate, Statix 160mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

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