Fortilink-C IBF System 65-C-1012-11-6L

GUDID 00191083006543

Interbody Fusion Device

Pioneer Surgical Technology, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00191083006543
• NIH Device Record Key: a6270f21-3ea2-4022-a65e-e05c6bcaae8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-C IBF System
• Version Model Number: 65-C-1012-11-6L
• Catalog Number: 65-C-1012-11-6L
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083006543 [Primary]
GS1	00846468080327 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192718

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar
• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-16
• Device Publish Date: 2021-02-08

On-Brand Devices [Fortilink-C IBF System]

• 00191083006703: Interbody Fusion Device
• 00191083006680: Interbody Fusion Device
• 00191083006673: Interbody Fusion Device
• 00191083006666: Interbody Fusion Device
• 00191083006635: Interbody Fusion Device
• 00191083006598: Interbody Fusion Device
• 00191083006581: Interbody Fusion Device
• 00191083006574: Interbody Fusion Device
• 00191083006543: Interbody Fusion Device
• 00191083006536: Interbody Fusion Device
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