True Lok System 99-56-13200

GUDID 18054242513100

TRUE LOK TRAUMA U-SUPPORT, 200MM STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 18054242513100
• NIH Device Record Key: a1e33a67-a6b8-4c7a-b293-a81ef3b4cbce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Lok System
• Version Model Number: 1
• Catalog Number: 99-56-13200
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242513100 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [True Lok System]

• 18054242513100: TRUE LOK TRAUMA U-SUPPORT, 200MM STERILE
• 18054242512752: K-WIRE, 550MM, OLIVE TL-HEX STERILE
• 18054242512745: K-WIRE, 450MM, NO OLIVE TL-HEX STERILE
• 18054242512639: DOUBLE ROW FOOTPLATE, 220MM, TL-HEX STERILE
• 18054242512622: DOUBLE ROW FOOTPLATE, 200MM, TL-HEX STERILE
• 18054242512615: DOUBLE ROW FOOTPLATE, 180MM, TL-HEX STERILE
• 18054242512608: DOUBLE ROW FOOTPLATE, 160MM, TL-HEX STERILE
• 18054242512592: DOUBLE ROW FOOTPLATE, 140MM, TL-HEX STERILE
• 18054242512585: DOUBLE ROW FOOTPLATE, 120MM, TL-HEX STERILE
• 18054242512578: 3/8 RING, 300MM, TL-HEX STERILE
• 18054242512561: 3/8 RING, 280MM, TL-HEX STERILE
• 18054242512554: 3/8 RING, 240MM, TL-HEX STERILE
• 18054242512547: 3/8 RING, 220MM, TL-HEX STERILE
• 18054242512479: MODULAR 5/8 RING, 300MM TL-HEX STERILE
• 18054242512462: MODULAR 5/8 RING, 280MM TL-HEX STERILE
• 18054242512455: MODULAR 5/8 RING, 240MM TL-HEX STERILE
• 18054242512448: MODULAR 5/8 RING, 220MM TL-HEX STERILE
• 18054242512370: FULL RING, 300MM, TL-HEX STERILE
• 18054242512363: FULL RING, 280MM, TL-HEX STERILE
• 18054242512356: FULL RING, 240MM, TL-HEX STERILE
• 18054242511847: TL-HEX APPLICATION SOFTWARE
• 18054242510772: 5/8 RING, 220MM, TL-HEX STERILE
• 18054242510727: FULL RING, 220MM, TL-HEX STERILE