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

Devices Manufactured by ORTHOFIX SRL

• 18052469476468 - ORTHOFIX: 2024-07-15 SIZING GUIDE
• 18052469476475 - ORTHOFIX: 2024-07-15 TARGETING HANDLE
• 18052469476482 - ORTHOFIX: 2024-07-15 TARGETING HANDLE - SHORT
• 18052469476499 - ORTHOFIX: 2024-07-15 ENTRY REAMER D12MM
• 18052469476505 - ORTHOFIX: 2024-07-15 ENTRY REAMER D13MM
• 18052469476512 - ORTHOFIX: 2024-07-15 FITBONE KIRSCHNER WIRE L280MM D3MM PACK OF 2 STERILE
• 18052469476529 - ORTHOFIX: 2024-07-15 SHORT SCREWDRIVER RETENTION ROD
• 18052469476536 - ORTHOFIX: 2024-07-15 LONG SCREWDRIVER RETENTION ROD