SKYHAWK

GUDID 18257200089543

22W X 50L X 0 DEG X 10H IMPLANT

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200089543
• NIH Device Record Key: 03c964e0-52d2-487a-87c5-54065ba5bd1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYHAWK
• Version Model Number: 27-3410
• 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	18257200089543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162446

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

Moist Heat or Steam Sterilization

[18257200089543]

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