Fortilink-C IBF System 65-C-TRL-S-6-6L

GUDID 00846468095697

Trial Spacer

Pioneer Surgical Technology, Inc.

Surgical implant template, reusable

• Primary Device ID: 00846468095697
• NIH Device Record Key: a7f0918e-711c-4fe2-af31-ecb5848f5947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-C IBF System
• Version Model Number: 65-C-TRL-S-6-6L
• Catalog Number: 65-C-TRL-S-6-6L
• 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
• 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 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
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• 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	00846468095697 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

[00846468095697]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

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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