Fortilink-A IBF System 65-A-M12-14L-TRL

GUDID 00846468093532

Anterior Trial Spacer

Pioneer Surgical Technology, Inc.

Surgical implant template, reusable

• Primary Device ID: 00846468093532
• NIH Device Record Key: bae67a15-9566-4fb0-afdb-f14e14bc86ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-A IBF System
• Version Model Number: 65-A-M12-14L-TRL
• Catalog Number: 65-A-M12-14L-TRL
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• 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: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468093532 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

[00846468093532]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [Fortilink-A IBF System]

• 00846468098414: V Shape Tamp
• 00846468094010: Interbody Fusion Device
• 00846468094003: Interbody Fusion Device
• 00846468093990: Interbody Fusion Device
• 00846468093983: Interbody Fusion Device
• 00846468093976: Interbody Fusion Device
• 00846468093969: Interbody Fusion Device
• 00846468093952: Interbody Fusion Device
• 00846468093945: Interbody Fusion Device
• 00846468093938: Interbody Fusion Device
• 00846468093921: Interbody Fusion Device
• 00846468093914: Interbody Fusion Device
• 00846468093907: Interbody Fusion Device
• 00846468093891: Anterior Trial Spacer
• 00846468093884: Anterior Trial Spacer
• 00846468093877: Anterior Trial Spacer
• 00846468093860: Anterior Trial Spacer
• 00846468093853: Anterior Trial Spacer
• 00846468093846: Anterior Trial Spacer
• 00846468093839: Anterior Trial Spacer
• 00846468093822: Anterior Trial Spacer
• 00846468093815: Anterior Trial Spacer
• 00846468093808: Anterior Trial Spacer
• 00846468093792: Anterior Trial Spacer
• 00846468093785: Anterior Trial Spacer
• 00846468093778: Anterior Trial Spacer
• 00846468093761: Anterior Trial Spacer
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• 00846468093648: Anterior Trial Spacer
• 00846468093631: Anterior Trial Spacer
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• 00846468093617: Anterior Trial Spacer
• 00846468093600: Anterior Trial Spacer
• 00846468093594: Anterior Trial Spacer
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• 00846468093549: Anterior Trial Spacer
• 00846468093532: Anterior Trial Spacer