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

eZ-Fix - 00841731109958 Catalog Number :

Device Description : Ring, Full 180mm Silver w/Tabs

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

eZ-Fix - 00841731109965 Catalog Number :

Device Description : Ring, Full 205mm Silver

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731109972 Catalog Number :

Device Description : Ring, Statix 3/8 140mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731109989 Catalog Number :

Device Description : Ring, Statix 3/8 160mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731109996 Catalog Number :

Device Description : Ring, Statix 3/8 180mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110008 Catalog Number :

Device Description : Ring, Statix 3/8 210mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110015 Catalog Number :

Device Description : Ring, Statix Half 140mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110022 Catalog Number :

Device Description : Ring, Statix Half 160mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110039 Catalog Number :

Device Description : Ring, Statix Half 180mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

STATIX - 00841731110046 Catalog Number :

Device Description : Ring, Statix Half 210mm Black

Device Class : 2

Duns Number: 152008371

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

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