Fortilink®-L IBF System with TETRAfuse 3D Technology 65-L-TRL14-8

GUDID 00846468086732

Fortilink-L IBF System Trial, 14mm (W) x 8mm (H)

Pioneer Surgical Technology, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 00846468086732
• NIH Device Record Key: e6e71454-c449-430b-ad34-10b06fb4b0fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink®-L IBF System with TETRAfuse 3D Technology
• Version Model Number: 65-L-TRL14-8
• Catalog Number: 65-L-TRL14-8
• 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

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	00846468086732 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

[00846468086732]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-24

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• 00846468087203: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 45mm (L
• 00846468087197: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L
• 00846468087180: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L
• 00846468087173: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L
• 00846468087166: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 50mm (L
• 00846468087159: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 45mm (L
• 00846468087142: Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L
• 00846468086756: Fortilink-L IBF System Trial, 22mm (W) x 8mm (H)
• 00846468086749: Fortilink-L IBF System Trial, 18mm (W) x 8mm (H)
• 00846468086732: Fortilink-L IBF System Trial, 14mm (W) x 8mm (H)