TRUELOK EVO 99-88014

GUDID 18052469472231

TL-HEX SET RINGS D200MM RX STRUTS MEDIUM STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use
Primary Device ID18052469472231
NIH Device Record Key2426e419-e93d-48ec-9e96-b908772d97bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUELOK EVO
Version Model Number1
Catalog Number99-88014
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118052469472231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-05
Device Publish Date2021-12-28

On-Brand Devices [TRUELOK EVO]

18052469472361TRUELOK EVO SPEEDBOLT PACK OF 2 STERILE
18052469472354TRUELOK EVO SPEEDNUT PACK OF 2 STERILE
18052469472347TRUELOK EVO 8MM HALF PIN FIX BOLT PACK OF 4 STERILE
18052469472330TRUELOK EVO HALF PIN FIXATION BOLT PACK OF 4 STERILE
18052469472323TRUELOK EVO BOLT PACK OF 4 L16.5MM STERILE
18052469472316TRUELOK EVO WIRE FIXATION BOLT PACK OF 4 STERILE
18052469472309TRUELOK EVO NUT WITH WASHER PACK OF 5 STERILE
18052469472293TRUELOK EVO CONN ELEMENT K WIRES CYLINDR PINS SET STERILE
18052469472286TRUELOK EVO CONNECTION ELEMENT CONICAL PINS SET STERILE
18052469472279TRUELOK EVO CONNECTION ELEMENT CYLINDR PINS SET STERILE
18052469472262TRUELOK EVO SET RX FOOTPLATE WITH RING D200MM RX STRUTS LONG STERILE
18052469472255TL-HEX SET FOOTPLATE WITH RING D180MM RX STRUTS LONG STERILE
18052469472248TL-HEX SET FOOTPLATE WITH RING D160MM RX STRUTS LONG STERILE
18052469472231TL-HEX SET RINGS D200MM RX STRUTS MEDIUM STERILE
18052469472224TL-HEX SET RINGS D200MM RX STRUTS LONG STERILE
18052469472217TL-HEX SET RINGS D180MM RX STRUTS MEDIUM STERILE
18052469472200TL-HEX SET RINGS D180MM RX STRUTS LONG STERILE
18052469472194TL-HEX SET RINGS D160MM RX STRUTS LONG STERILE
18052469472187TL-HEX SET RINGS D160MM RX STRUTS LONG STERILE
18052469472170TRUELOK EVO SET RX FOOTPLATE WITH RING D180MM RX STRUTS LONG STERILE
18052469472163TRUELOK EVO SET RX FOOTPLATE WITH RING D160MM RX STRUTS LONG STERILE
18052469472156TRUELOK EVO SET RX RINGS D200MM RX STRUTS MEDIUM STERILE
18052469472149TRUELOK EVO SET RX RINGS D200MM RX STRUTS LONG STERILE
18052469472132TRUELOK EVO SET RX RINGS D180MM RX STRUTS MEDIUM STERILE
18052469472125TRUELOK EVO SET RX RINGS D180MM RX STRUTS LONG STERILE
18052469472118TRUELOK EVO SET RX RINGS D160MM RX STRUTS MEDIUM STERILE
18052469472101TRUELOK EVO SET RX RINGS D160MM RX STRUTS LONG STERILE
18052469472095TRUELOK EVO RX STRUT MEDIUM STATIC STERILE
18052469472088TRUELOK EVO RX STRUT MEDIUM WITH DYNA STERILE
18052469472071TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
18052469472064TRUELOK EVO RX FOOT ARCH D200MM STERILE
18052469472057TRUELOK EVO RX FOOT ARCH D180MM STERILE
18052469472040TRUELOK EVO RX FOOT ARCH D160MM STERILE
18052469472033TRUELOK EVO RX FOOT ARCH D140MM STERILE
18052469472026TRUELOK EVO RX FOOTPLATE D200MM STERILE
18052469472019TRUELOK EVO RX FOOTPLATE D180MM STERILE
18052469472002TRUELOK EVO RX FOOTPLATE D160MM STERILE
18052469471999TRUELOK EVO RX FOOTPLATE D140MM STERILE
18052469471982TRUELOK EVO RX FULL RING D200MM STERILE
18052469471975TRUELOK EVO RX FULL RING D180MM STERILE
18052469471968TRUELOK EVO RX FULL RING D160MM STERILE
18052469471951TRUELOK EVO RX FULL RING D140MM STERILE
18052469471944TRUELOK EVO RX 3/8 MODULAR RING D200MM STERILE
18052469471937TRUELOK EVO RX 3/8 MODULAR RING D180MM STERILE
18052469471920TRUELOK EVO RX 3/8 MODULAR RING D160MM STERILE
18052469471913TRUELOK EVO RX 3/8 MODULAR RING D140MM STERILE
18052469471906TRUELOK EVO RX 5/8 MODULAR RING D200MM STERILE
18052469471890TRUELOK EVO RX 5/8 MODULAR RING D180MM STERILE
18052469471883TRUELOK EVO RX 5/8 MODULAR RING D160MM STERILE
18052469471876TRUELOK EVO RX 5/8 MODULAR RING D140MM STERILE
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