ORTHOFIX SRL

Address:VIA DELLE NAZIONI 9,BUSSOLENGO Verona,IT

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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, Metal Composite (LXT) (8) Rod, Fixation, Intramedullary And Accessories (HSB) (1) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

Yes No

Clear

TRUELOK SYSTEM - 18056099649544 Catalog Number : 81641

Device Description : TL PLUS 90° PLATE 1 HOLE

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649551 Catalog Number : 81642

Device Description : TL PLUS 90° PLATE 2 HOLES

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649568 Catalog Number : 81643

Device Description : TL PLUS 90° PLATE 3 HOLES

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649575 Catalog Number : 450502

Device Description : TL PLUS FOOT&ANKLE KIT TRAY EMPTY

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649582 Catalog Number : 450502-01

Device Description : TL PLUS FOOT&ANKLE KIT LID

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649599 Catalog Number : 450502-02

Device Description : TL PLUS FOOT&ANKLE KIT BASE

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649605 Catalog Number : 450502C

Device Description : TL PLUS FOOT&ANKLE KIT TRAY COMPLETE

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649612 Catalog Number : 54-1143M

Device Description : TL PLUS WASHER 4 MM THICK (PACK OF 10)

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

TRUELOK SYSTEM - 18056099649629 Catalog Number : 50-1010M

Device Description : TL PLUS NYLON INSERT NUT (PACK OF 10)

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

AGILE NAIL - 18056099649636 Catalog Number : 183260

Device Description : CANNULATED AWL

Device Class : 2

Duns Number: 438793622

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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