Fortilink-L IBF System with TETRAfuse 3D Technology 65-L-1850-11-12L

GUDID 00846468086558

Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L), 11mm (H), 12° Lordosis

Pioneer Surgical Technology, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00846468086558
• NIH Device Record Key: 4bdf574e-b30a-4075-9823-8ec07d6133e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-L IBF System with TETRAfuse 3D Technology
• Version Model Number: 65-L-1850-11-12L
• Catalog Number: 65-L-1850-11-12L
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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: 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
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• Phone: +1(386)418-8888
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• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083007304 [Primary]
GS1	00846468086558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172343
• Premarket Notification: K192718

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-10-30

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