Fortilink-C 65-C-1214-8-6L

GUDID 00846468080365

FORTILINK-C Tetrafuse 12x14 8mm, 6L

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Vertebral body prosthesis Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00846468080365
• NIH Device Record Key: eed71cba-da0c-4ae5-91a4-c8850cde4b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-C
• Version Model Number: 65-C-1214-8-6L
• Catalog Number: 65-C-1214-8-6L
• 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
• 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
• 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
• 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
• 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
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083006659 [Primary]
GS1	00846468080365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163673
• 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-26

On-Brand Devices [Fortilink-C]

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• 00846468080457: FORTILINK-C Tetrafuse 14.5x17 10mm, 6L
• 00846468080440: FORTILINK-C Tetrafuse 14.5x17 9mm, 6L
• 00846468080433: FORTILINK-C Tetrafuse 14.5x17 8mm, 6L
• 00846468080426: FORTILINK-C Tetrafuse 14.5x17 7mm, 6L
• 00846468080419: FORTILINK-C Tetrafuse 14.5x17 6mm, 6L
• 00846468080402: FORTILINK-C Tetrafuse 14.5x17 5mm, 6L
• 00846468080396: FORTILINK-C Tetrafuse 12x14 11mm, 6L
• 00846468080389: FORTILINK-C Tetrafuse 12x14 10mm, 6L
• 00846468080372: FORTILINK-C Tetrafuse 12x14 9mm, 6L
• 00846468080365: FORTILINK-C Tetrafuse 12x14 8mm, 6L
• 00846468080358: FORTILINK-C Tetrafuse 12x14 7mm, 6L
• 00846468080341: FORTILINK-C Tetrafuse 12x14 6mm, 6L
• 00846468080334: FORTILINK-C Tetrafuse 12x14 5mm, 6L
• 00846468080327: FORTILINK-C Tetrafuse 10x12 11mm, 6L
• 00846468080310: FORTILINK-C Tetrafuse 10x12 10mm, 6L
• 00846468080303: FORTILINK-C Tetrafuse 10x12 9mm, 6L
• 00846468080297: FORTILINK-C Tetrafuse 10x12 8mm, 6L
• 00846468080280: FORTILINK-C Tetrafuse 10x12 7mm, 6L
• 00846468080273: FORTILINK-C Tetrafuse 10x12 6mm, 6L
• 00846468080266: Fortilink-C Slaphammer
• 00846468080259: Fortilink-C Inserter Housing w/Slaphammer
• 00846468080242: Fortilink-C Tamp, Large
• 00846468080235: Fortilink-C Tamp, Small
• 00846468080228: Fortilink-C Inserter Housing
• 00846468080211: Fortilink-C Case
• 00846468080204: FORTILINK-C Tetrafuse 10x12 5mm, 6L
• 00846468080198: Fortilink-C Inserter Fork Large
• 00846468080181: Fortilink-C Inserter Fork Small