TRUELOK SYSTEM 54-1141

GUDID 18056099649407

TL PLUS TENSION LIMITER

ORTHOFIX SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID18056099649407
NIH Device Record Key7cbc3a2b-2340-4497-b581-1b3ebf51ced9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUELOK SYSTEM
Version Model Number1
Catalog Number54-1141
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118056099649407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


[18056099649407]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-17
Device Publish Date2018-04-24

On-Brand Devices [TRUELOK SYSTEM ]

18056099649667TL-HEX LONG STRUT L158MM-318MM STERILE
18056099649650TL-HEX MEDIUM STRUT L114MM-184MM STERILE
18056099649643TL-HEX SHORT STRUT L92MM-122MM STERILE
18056099649629TL PLUS NYLON INSERT NUT (PACK OF 10)
18056099649612TL PLUS WASHER 4 MM THICK (PACK OF 10)
18056099649605TL PLUS FOOT&ANKLE KIT TRAY COMPLETE
18056099649599TL PLUS FOOT&ANKLE KIT BASE
18056099649582TL PLUS FOOT&ANKLE KIT LID
18056099649575TL PLUS FOOT&ANKLE KIT TRAY EMPTY
18056099649568TL PLUS 90° PLATE 3 HOLES
18056099649551TL PLUS 90° PLATE 2 HOLES
18056099649544TL PLUS 90° PLATE 1 HOLE
18056099649537TL PLUS TWISTED PLATE 4 HOLES
18056099649520TL PLUS TWISTED PLATE 3 HOLES
18056099649513TL PLUS TWISTED PLATE 2 HOLES
18056099649506TL PLUS NYLON INSERT NUT
18056099649490TL PLUS THREADED HINGE ROD L30MM
18056099649483TL PLUS NON LOCKABLE UNIVERSAL JOINT
18056099649476TL PLUS HINGE MALE LOW PROFILE
18056099649469TL PLUS HINGE MALE HIGH PROFILE
18056099649452TL PLUS 90° HINGE LOW PROFILE
18056099649445TL PLUS 90° HINGE HIGH PROFILE
18056099649438TL PLUS HINGE FEMALE LOW PROFILE
18056099649421TL PLUS HINGE FEMALE HIGH PROFILE
18056099649414TL PLUS WASHER 4 MM THICK
18056099649407TL PLUS TENSION LIMITER
18056099649391TL PLUS X-WIRE WITHOUT OLIVE L300MM D1.5MM
18056099649384TL PLUS X-WIRE WITH OLIVE L300MM D1.5MM
18056099649377TL PLUS BAYONET WIRE WITHOUT OLIVE L300MM D1.5MM
18056099649360TL PLUS BAYONET WIRE WITH OLIVE L300MM D1.5MM
18054242517351TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L70MM STERILE
18054242517344TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L200MM STERILE
18054242517337TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L150MM STERILE
18054242517320TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L100MM STERILE
18054242517313TL-HEX STRUT DIRECTION CLIP KIT (PACK OF 6) STERILE
18054242517306TL-HEX STRUT NUMBER CLIP KIT (PACK OF 6) STERILE
18054242517290TRUELOK PLUS HALF PIN QUICK CONNECT D6MM L180MM STERILE
18054242517283TRUELOK PLUS HALF PIN QUICK CONNECT D5MM L180MM STERILE
18054242517276TRUELOK PLUS HALF PIN QUICK CONNECT D4MM L180MM STERILE
18054242517269TL-HEX EMERGENCY TAB KIT STERILE
18054242517252TL-HEX 3/8 RING D200MM STERILE
18054242517245TL-HEX 3/8 RING D180MM STERILE
18054242517238TL-HEX 3/8 RING D160MM STERILE
18054242517221TL-HEX 3/8 RING D140MM STERILE
18054242517214TL-HEX 3/8 RING D120MM STERILE
18054242517207TL-HEX 3/8 RING D100MM STERILE
18054242517191TL-HEX MODULAR 5/8 RING D200MM STERILE
18054242517184TL-HEX MODULAR 5/8 RING D180MM STERILE
18054242517177TL-HEX MODULAR 5/8 RING D160MM STERILE
18054242517160TL-HEX MODULAR 5/8 RING D140MM STERILE

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