TRUELOK SYSTEM 450504

GUDID 18032937160419

HINGES AND DISTRACTORS TRAY, TRUELOK, EMPTY

ORTHOFIX SRL

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• Primary Device ID: 18032937160419
• NIH Device Record Key: 753f42b0-6d63-4dc5-8a42-3bf3a10fe265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUELOK SYSTEM
• Version Model Number: 1
• Catalog Number: 450504
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032937160419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941048

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

[18032937160419]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-19

On-Brand Devices [TRUELOK SYSTEM ]

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