Fortilink-A IBF System 65-A-L16-14L

GUDID 00846468093112

Interbody Fusion Device

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468093112
• NIH Device Record Key: 2670009b-4fb0-4b3e-93c6-3269afa2bd5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-A IBF System
• Version Model Number: 65-A-L16-14L
• Catalog Number: 65-A-L16-14L
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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: +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	00846468093112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192718

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2020-01-10

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• 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
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• 00846468093846: Anterior Trial Spacer
• 00846468093839: Anterior Trial Spacer
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• 00846468093815: Anterior Trial Spacer
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• 00846468093785: Anterior Trial Spacer
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• 00846468093761: Anterior Trial Spacer
• 00846468093754: Anterior Trial Spacer
• 00846468093747: Anterior Trial Spacer
• 00846468093730: Anterior Trial Spacer
• 00846468093723: Anterior Trial Spacer
• 00846468093716: Anterior Trial Spacer
• 00846468093709: Anterior Trial Spacer
• 00846468093693: Anterior Trial Spacer
• 00846468093686: Anterior Trial Spacer
• 00846468093679: Anterior Trial Spacer
• 00846468093662: Anterior Trial Spacer
• 00846468093655: Anterior Trial Spacer
• 00846468093648: Anterior Trial Spacer
• 00846468093631: Anterior Trial Spacer
• 00846468093624: Anterior Trial Spacer
• 00846468093617: Anterior Trial Spacer
• 00846468093600: Anterior Trial Spacer
• 00846468093594: Anterior Trial Spacer
• 00846468093587: Anterior Trial Spacer
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• 00846468093532: Anterior Trial Spacer