Xcaliber Bone Screws 99-948335

GUDID 18054242512219

SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 120/35 QC STERILE

ORTHOFIX SRL

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 18054242512219
• NIH Device Record Key: 40706a13-fbec-4205-82ab-328b1e9e6a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcaliber Bone Screws
• Version Model Number: 1
• Catalog Number: 99-948335
• 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
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242512219 [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 Bone Screws]

• 18054242518662: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/90QC STERILE
• 18054242518655: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/80QC STERILE
• 18054242518648: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/70QC STERILE
• 18054242518631: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/60QC STERILE
• 18054242518624: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/50QC STERILE
• 18054242518617: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L260/40QC STERILE
• 18054242518600: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L220/70QC STERILE
• 18054242518594: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L220/60QC STERILE
• 18054242518587: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L220/50QC STERILE
• 18054242518570: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L220/40QC STERILE
• 18054242518563: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L180/60QC STERILE
• 18054242518556: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L180/50QC STERILE
• 18054242518549: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L180/40QC STERILE
• 18054242518532: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L150/50QC STERILE
• 18054242518525: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L150/40QC STERILE
• 18054242518518: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L150/35QC STERILE
• 18054242518501: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L150/30QC STERILE
• 18054242518495: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L120/40QC STERILE
• 18054242518488: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L120/35QC STERILE
• 18054242518471: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D6MM THREAD 5MM L120/30QC STERILE
• 18054242516026: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/90 QC
• 18054242516019: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/80 QC
• 18054242516002: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/70 QC
• 18054242515999: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/60 QC
• 18054242515982: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/50 QC
• 18054242515975: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 260/40 QC
• 18054242515968: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 220/70 QC
• 18054242515951: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 220/60 QC
• 18054242515944: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 220/50 QC
• 18054242515937: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 220/40 QC
• 18054242515920: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 5MM L.180/60 QC
• 18054242515913: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 5MM L.180/50 QC
• 18054242515906: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 5MM L.180/40 QC
• 18054242515890: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 150/50 QC
• 18054242515883: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 150/40 QC
• 18054242515876: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 150/35 QC
• 18054242515869: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 150/30 QC
• 18054242515852: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 120/40 QC
• 18054242515845: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 120/35 QC
• 18054242515838: SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6mm THREAD 5 mm L 120/30 QC
• 18054242513599: XCALIBER BONE SCREW STERILE L150/20MM THREAD D 6.0-5.6MM
• 18054242513582: XCALIBER OSTEOTITE SCREW L 150/20 MM THREAD D 6.0-5.6MM
• 18054242512646: BONE SCREW HAND DRILL STERILE
• 18054242512219: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 120/35 QC STERILE
• 18054242512202: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 120/25 QC STERILE
• 18054242512196: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 120/20 QC STERILE
• 18054242512189: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 100/25 QC STERILE
• 18054242512172: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 100/20 QC STERILE
• 18054242512165: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 4MM 180/40 QC STERILE
• 18054242512158: SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 4MM 180/30 QC STERILE