Xcaliber External Fixator 99-91647JP

GUDID 18032937169702

JP XCALIBER ANKLE COMPLETE KIT

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 18032937169702
• NIH Device Record Key: ffb4735b-3e47-4906-b310-be02c34668e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcaliber External Fixator
• Version Model Number: 1
• Catalog Number: 99-91647JP
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	18032937169702 [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

On-Brand Devices [Xcaliber External Fixator]

• 18032937169719: UE XCALIBER ANKLE COMPLETE KIT
• 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.