Fortilink-TS IBF System with TETRAfuse 3D Technology 65-TS-16-22-6L

GUDID 00846468084257

Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 22mm (L), 6° Lordosis

Pioneer Surgical Technology, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00846468084257
• NIH Device Record Key: 05057921-a501-4b7e-8f3f-64ada62f1e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-TS IBF System with TETRAfuse 3D Technology
• Version Model Number: 65-TS-16-22-6L
• Catalog Number: 65-TS-16-22-6L
• 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
• 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(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.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
• 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
• 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
• 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
• 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
• 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
• 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	00191083008738 [Primary]
GS1	00846468084257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172343
• 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: 2017-10-30

On-Brand Devices [Fortilink-TS IBF System with TETRAfuse 3D Technology]

• 00846468084332: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 32mm (
• 00846468084325: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 26mm (
• 00846468084318: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 26mm (
• 00846468084301: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 22mm (
• 00846468084295: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 22mm (
• 00846468084288: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 32mm (
• 00846468084271: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 26mm (
• 00846468084264: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 26mm (
• 00846468084257: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 22mm (
• 00846468084240: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 22mm (
• 00846468084233: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 32mm (
• 00846468084226: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 26mm (
• 00846468084219: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 26mm (
• 00846468084202: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 22mm (
• 00846468084196: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 22mm (
• 00846468084189: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 32mm (
• 00846468084172: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 26mm (
• 00846468084165: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 26mm (
• 00846468084158: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 22mm (
• 00846468084141: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 22mm (
• 00846468084134: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 32mm (
• 00846468084127: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 26mm (
• 00846468084110: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 26mm (
• 00846468084103: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 22mm (
• 00846468084097: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 22mm (
• 00846468084080: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 32mm (
• 00846468084073: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 26mm (
• 00846468084066: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 26mm (
• 00846468084059: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 22mm (
• 00846468084042: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 22mm (
• 00846468084035: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 32mm (
• 00846468084028: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 26mm (
• 00846468084011: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 26mm (
• 00846468084004: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 22mm (
• 00846468083991: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 22mm (
• 00846468083984: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 32mm (
• 00846468083977: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 26mm (
• 00846468083960: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 26mm (
• 00846468083953: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 22mm (
• 00846468083946: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 22mm (
• 00846468083939: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 26mm (L
• 00846468083922: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 26mm (L
• 00846468083915: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 22mm (L
• 00846468083908: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 22mm (L
• 00846468083892: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 26mm (L
• 00846468083885: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 26mm (L
• 00846468083878: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 22mm (L
• 00846468083861: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 22mm (L