XCALIBER EXTERNAL FIXATOR 900040

GUDID 18053504369752

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18053504369752
• NIH Device Record Key: e15afd77-5d5f-47f5-af05-da1f02f5e5ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XCALIBER EXTERNAL FIXATOR
• Version Model Number: 1
• Catalog Number: 900040
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504369752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18053504369752]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [XCALIBER EXTERNAL FIXATOR ]

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• 18032937169702: JP XCALIBER ANKLE COMPLETE KIT
• 18032937169696: UE XCALIBER METADIAPHYSEAL COMPLETE KIT
• 18032937169689: JP XCALIBER METADIAPHYSEAL COMPLETE KIT
• 18032937167791: US XCALIBER ANKLE COMPLETE KIT
• 18032937167784: US XCALIBER METADIAPHYSEAL COMPLETE KIT
• 18032568867299: XCALIBER/PROCALLUS HYBRID INSTRUMENTS STERIBOX, EMPTY
• 18032568867282: XCALIBER META-DIAPHYSEAL/ANKLE INSTRUMENTS STERIBOX, EMPTY
• 18032568867213: XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
• 18032568867206: XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
• 18032568863352: XCALIBER HYBRID KIT STERILE
• 18032568863345: XCALIBER ARTICULATED ANKLE KIT STERILE
• 18032568863338: SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE
• 18032568863321: XCALIBER DYNAMIC C/D UNIT STERILE
• 18032568863307: XCALIBER META-DIAPHYSEAL KIT STERILE
• 18032568861617: RADIOLUCENT ANKLE PIN GUIDE STERILE
• 18032568861600: CANNULATED DRILL BIT WITH WIRE D 3.2 MM LENGTH 150 MM STERILE
• 18032568861358: SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 150 MM
• 18032568861341: UNIVERSAL ALLEN WRENCH
• 18032568861259: SUPPLEMENTARY SCREW HOLDER
• 18032568035216: XCALIBER MANIPULATION FORCEPS
• 18053504369752: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.