Xcaliber Bone Screws 99-911560

GUDID 18032568863390

XCALIBER BONE SCREW STERILE L150/60MM THREAD D6.0-5.6MM

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 18032568863390
• NIH Device Record Key: 63cb587b-b0a7-4b72-91b6-f929ea987b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcaliber Bone Screws
• Version Model Number: 1
• Catalog Number: 99-911560
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 150 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568863390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

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

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• 18059015375879 - TRUELOK SYSTEM: 2025-01-13 TRUELOK ELEVATE INSTRUMENT TRAY COMPLETE
• 18059015375886 - TRUELOK SYSTEM: 2025-01-13 TRUELOK ELEVATE INSTRUMENT TRAY BASE
• 18059015375893 - TRUELOK SYSTEM: 2025-01-13 TRUELOK ELEVATE INSTRUMENT TRAY LID
• 18059015375909 - TRUELOK SYSTEM: 2025-01-13 TRUELOK ELEVATE EXTERNAL FIXATOR
• 18059015375916 - TRUELOK SYSTEM: 2025-01-13 TRUELOK ELEVATE TEMPLATE