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

Passer, Wire, Orthopedic (HXI) (6) Bit, Drill (HTW) (2) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Vilex Power Accessory - 00841731122261 Catalog Number : K16150-06TN

Device Description : Kwire .062x6" (1.6x150mm) Threaded

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Vilex Power Accessory - 00841731122278 Catalog Number : K16150-12N

Device Description : KWire .062x6" (1.6x150mm)

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Vilex Power Accessory - 00841731122285 Catalog Number : K16225-12N

Device Description : KWire .062x9" (1.6x225mm)

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Vilex Power Accessory - 00841731122292 Catalog Number : K18225-12N

Device Description : Kwire .070X9" (1.8x225mm)

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Vilex Power Accessory - 00841731122308 Catalog Number : K20225-12N

Device Description : KWire .078 x 9"(2.0x225mm))

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Vilex Power Accessory - 00841731122315 Catalog Number : K24225-12N

Device Description : KWire .094 x 9" (2.4x225mm)

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

eZ-Fix Tool - 00841731122339 Catalog Number :

Device Description : Tensioner, Short Nose

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

eZ-Fix Tool - 00841731122346 Catalog Number :

Device Description : Tensioner, Long Nose

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Vilex Cannulated Drill - 00841731123091 Catalog Number :

Device Description : Drill, Jones Fracture 3.3x175mm

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Vilex Cannulated Drill - 00841731123107 Catalog Number :

Device Description : Drill, Jones Fracture 4.15x175mm

Device Class : 1

Duns Number: 152008371

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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