SKYHAWK

GUDID 18257200087754

5.5 X 60MM BONE SCREW

ORTHOFIX INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 18257200087754
• NIH Device Record Key: af269d24-22cb-42a4-82db-a7ea84dd5c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYHAWK
• Version Model Number: 24-5560
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200087754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140260

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

[18257200087754]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-12

On-Brand Devices [SKYHAWK]

• 18257200126088: SKYHAWK - BOTTOM LEVEL TRAY, INTERBODY INSTRUMENT CASE
• 18257200126071: SKYHAWK - TOP LEVEL TRAY, INTERBODY INSTRUMENT CASE
• 18257200126064: SKYHAWK - BASE, INTERBODY 22W IMPLANT CASE
• 18257200126057: SKYHAWK - INTERBODY 22W IMPLANT CASE
• 18257200126040: SKYHAWK - BASE, INTERBODY 18W IMPLANT CASE
• 18257200126033: SKYHAWK - INTERBODY 18W IMPLANT CASE
• 18257200126026: SKYHAWK - BASE, INTERBODY INSTRUMENT CASE
• 18257200126019: SKYHAWK - INTERBODY INSTRUMENT CASE
• 18257200126002: BOTTOM TRAY, GENERAL DISCECTOMY CASE #2
• 18257200125999: TOP TRAY, GENERAL DISCECTOMY CASE #2
• 18257200125982: BOTTOM TRAY, GENERAL DISCECTOMY CASE #1
• 18257200125975: TOP TRAY, GENERAL DISCECTOMY CASE #1
• 18257200125937: GENERAL DISCECTOMY CASE #1
• 18257200125906: SKYHAWK - LATERAL PLATE CADDY, LATERAL PLATE CASE
• 18257200125890: SKYHAWK - BONE SCREW CADDY, LATERAL PLATE CASE
• 18257200125883: SKYHAWK - SET SCREW CADDY, LATERAL PLATE CASE
• 18257200125876: SKYHAWK - BASE, LATERAL PLATE CASE
• 18257200125869: SKYHAWK - LATERAL PLATE CASE
• 18257200110629: SKYHAWK - INTERBODY INSTRUMENT TRAY KIT
• 18257200108916: DRIVER
• 18257200108909: FINAL TIGHTENING DRIVER
• 18257200108893: 5.5MM DRILL
• 18257200108886: AWL
• 18257200108879: AWL SLEEVE
• 18257200108862: RONGEUR, BONE BITING
• 18257200108855: MODULAR IN-LINE HANDLE
• 18257200105564: K-WIRE
• 18257200103089: 22W X 60L X 8 DEGREE X 20H TRIAL
• 18257200103072: 22W X 60L X 8 DEGREE X 19H TRIAL
• 18257200103065: 22W X 60L X 8 DEGREE X 18H TRIAL
• 18257200103058: 22W X 60L X 8 DEGREE X 17H TRIAL
• 18257200103041: 22W X 60L X 8 DEGREE X 16H TRIAL
• 18257200103034: 22W X 60L X 8 DEGREE X 15H TRIAL
• 18257200103027: 22W X 60L X 8 DEGREE X 14H TRIAL
• 18257200103010: 22W X 60L X 8 DEGREE X 13H TRIAL
• 18257200103003: 22W X 60L X 8 DEGREE X 12H TRIAL
• 18257200102990: 22W X 60L X 8 DEGREE X 11H TRIAL
• 18257200102983: 22W X 60L X 8 DEGREE X 10H TRIAL
• 18257200102976: 22W X 60L X 8 DEGREE X 9H TRIAL
• 18257200102969: 22W X 60L X 8 DEGREE X 8H TRIAL
• 18257200102952: 18W X 60L X 8 DEGREE X 20H TRIAL
• 18257200102945: 18W X 60L X 8 DEGREE X 19H TRIAL
• 18257200102938: 18W X 60L X 8 DEGREE X 18H TRIAL
• 18257200102921: 18W X 60L X 8 DEGREE X 17H TRIAL
• 18257200102914: 18W X 60L X 8 DEGREE X 16H TRIAL
• 18257200102907: 18W X 60L X 8 DEGREE X 15H TRIAL
• 18257200102891: 18W X 60L X 8 DEGREE X 14H TRIAL
• 18257200102884: 18W X 60L X 8 DEGREE X 13H TRIAL
• 18257200102877: 18W X 60L X 8 DEGREE X 12H TRIAL
• 18257200102860: 18W X 60L X 8 DEGREE X 11H TRIAL