Bone Screws SS10197

GUDID 18032568864342

SELF-DRILL CORT SCREW 90/20MM SHAFT D6MM THREAD D 4.5-3.5MM

ORTHOFIX SRL

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 18032568864342
• NIH Device Record Key: f327f7b9-193e-490e-b554-4824eff959f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Screws
• Version Model Number: 1
• Catalog Number: SS10197
• 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: 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: +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
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568864342 [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

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

[18032568864342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Bone Screws]

• 18033509851902: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/15 MM D 3.0-2.5 MM
• 18033509851896: SELF-DRILLING CANCELLOUS SCREW STERILE LENGTH 90/35 MM D 4.0-3.5 MM
• 18033509851889: SELF-DRILL CORT SCREW 100/30MM STERILE THREAD DIA. 3-2.5 MM
• 18033509851872: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/30 MM D 3.0-2.5 MM
• 18033509851865: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/25 MM D 3.0-2.5 MM
• 18033509851858: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/20 MM D 3.0-2.5 MM
• 18033509851841: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/30 MM D 3.0-2.5 MM
• 18033509851834: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/25 MM D 3.0-2.5 MM
• 18033509851827: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/20 MM D 3.0-2.5 MM
• 18033509851810: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 50/18 MM D 3.0-2.5 MM
• 18033509851803: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 45/20 MM D 2.5-2.0 MM
• 18033509851797: SELF-DRILLING CORTICAL SCREW STERILE LENGTH 40/15 MM D 2.5-2.0 MM
• 18033509850509: SELF-DRILL CORT SCREW 120/40MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850493: CORTICAL SCREW 80/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850486: CORTICAL SCREW 70/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850462: SELF-DRILL CORT SCREW 250/80MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850455: SELF-DRILL CORT SCREW 220/50MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850448: SELF-DRILL CORT SCREW 220/40MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850431: SELF-DRILL CORT SCREW 150/40MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850424: CORTICAL SCREW 200/90 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850417: CORTICAL SCREW 170/80 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850400: CORTICAL SCREW 160/70 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850394: CORTICAL SCREW 150/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850387: CORTICAL SCREW 120/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850370: CORTICAL SCREW 100/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850363: CORTICAL SCREW 100/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850356: CORTICAL SCREW 90/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850349: CORTICAL SCREW 80/30 MM STERILE SHAFT D 6MM THREAD D 3.5-3.2MM
• 18033509850332: CORTICAL SCREW 70/20 MM STERILE SHAFT D 6MM THREAD D 3.5-3.2MM
• 18033509850325: CORTICAL SCREW 170/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850318: CORTICAL SCREW 170/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850301: CORTICAL SCREW 160/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850295: CORTICAL SCREW 150/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850288: CORTICAL SCREW 130/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850271: CORTICAL SCREW 130/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850264: CORTICAL SCREW 120/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850257: CORTICAL SCREW 120/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850240: CORTICAL SCREW 100/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850233: CORTICAL SCREW 100/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850158: CORTICAL SCREW 200/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850141: CORTICAL SCREW 200/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850134: CORTICAL SCREW 130/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850127: SELF-DRILL CORT SCREW 150/50MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850110: CORTICAL SCREW 180/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850103: CORTICAL SCREW 150/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850097: CORTICAL SCREW 110/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
• 18033509850080: CORTICAL SCREW 80/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850073: CORTICAL SCREW 120/40 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850066: CORTICAL SCREW 100/40 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
• 18033509850059: SELF-DRILL CORT SCREW 220/60MM STERILE SHAFT D 6 MM THREAD D 6-5 MM