VILEX LLC

Address:111 MOFFITT ST,MCMINNVILLE,TN,37110,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, Nail/Blade/Plate Combination, Multiple Component (KTT) (7) Orthopedic Manual Surgical Instrument (LXH) (3)

Premarket Exempt

No Yes

Clear

Dynex - 00841731125781 Catalog Number :

Device Description : Bolt, Half Pin w/Washer

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125798 Catalog Number : 661-17

Device Description : Bolt, Half Pin Washerless

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125804 Catalog Number :

Device Description : Nut, Thrd Coupling 18mm

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125842 Catalog Number :

Device Description : Nut, Thrd coupling 40mm

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125866 Catalog Number :

Device Description : Nut, Thrd coupling 60mm

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125897 Catalog Number :

Device Description : Spring, Shoe Suspension (4/pk)

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125941 Catalog Number :

Device Description : Tensioner, Wire

Device Class : 1

Duns Number: 117502293

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125958 Catalog Number :

Device Description : Shoe, (Pair)

Device Class : 2

Duns Number: 117502293

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125965 Catalog Number :

Device Description : Nose, Long, Tensioner

Device Class : 1

Duns Number: 117502293

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Dynex - 00841731125972 Catalog Number :

Device Description : Nose, Short, Tensioner

Device Class : 1

Duns Number: 117502293

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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