VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 003-B-01001

GUDID 18056099647762

T-PLATE, SMALL

ORTHOFIX SRL

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 18056099647762
• NIH Device Record Key: 754b82d6-340e-406c-9352-14df2dce7846
• Commercial Distribution Discontinuation: 2019-10-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM
• Version Model Number: 1
• Catalog Number: 003-B-01001
• 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: false
• 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: +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	18056099647762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140876

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-29
• Device Publish Date: 2017-06-07

On-Brand Devices [VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM]

• 18056099647977: DRILL GUIDE (LOCKING AND NON-LOCKING)
• 18056099647960: H-PLATE, 30MM
• 18056099647953: H-PLATE, 25MM
• 18056099647939: H-PLATE, 20MM
• 18056099647915: H-PLATE, 15MM
• 18056099647908: H-PLATE, 12MM
• 18056099647892: BOX PLATE, 30MM
• 18056099647878: BOX PLATE, 22MM
• 18056099647854: BOX PLATE, 18MM
• 18056099647847: L-PLATE, RIGHT
• 18056099647830: L-PLATE, LEFT
• 18056099647823: STRAIGHT PLATE, 6 HOLE
• 18056099647816: STRAIGHT PLATE, 4 HOLE
• 18056099647809: STRAIGHT PLATE, 3 HOLE
• 18056099647793: Y-PLATE, LARGE
• 18056099647786: Y-PLATE, SMALL
• 18056099647779: T-PLATE, LARGE
• 18056099647762: T-PLATE, SMALL
• 18056099647755: EVANS PLATE, 12MM SPACER
• 18056099647748: EVANS PLATE, 10MM SPACER
• 18056099647731: EVANS PLATE, 8MM SPACER
• 18056099647724: EVANS PLATE, 6MM SPACER
• 18056099647717: CC PLATE, LARGE
• 18056099647700: CC PLATE, MEDIUM
• 18056099647694: CC PLATE, SMALL
• 18056099647687: TN PLATE, LARGE
• 18056099647670: TN PLATE, MEDIUM
• 18056099647663: TN PLATE, SMALL
• 18056099647656: LAPIDUS PLATE, LARGE, 2MM STEP, RIGHT
• 18056099647649: LAPIDUS PLATE, LARGE, 2MM STEP, LEFT
• 18056099647632: LAPIDUS PLATE, LARGE, 0MM STEP, RIGHT
• 18056099647625: LAPIDUS PLATE, LARGE, 0MM STEP, LEFT
• 18056099647618: LAPIDUS PLATE, SMALL, 2MM STEP, RIGHT
• 18056099647601: LAPIDUS PLATE, SMALL, 2MM STEP, LEFT
• 18056099647595: LAPIDUS PLATE, SMALL, 0MM STEP, RIGHT
• 18056099647588: LAPIDUS PLATE, SMALL, 0MM STEP, LEFT
• 18056099647571: MTP PLATE, LARGE
• 18056099647564: MTP PLATE, MEDIUM
• 18056099647557: MTP PLATE, SMALL