Fortilink-TS IBF System 65-TS-16-32

GUDID 00191083008769

Interbody Fusion Device

Pioneer Surgical Technology, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00191083008769
• NIH Device Record Key: 88b90e52-198c-40ca-a422-d3c28f0b0ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink-TS IBF System
• Version Model Number: 65-TS-16-32
• Catalog Number: 65-TS-16-32
• 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
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)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	00191083008769 [Primary]
GS1	00846468084288 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192718

FDA Product Code

• 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-TS IBF System]

• 00846468086503: Fortilink-TS IBF System Instrument Case
• 00846468084981: Fortilink-TS IBF System Tamp, Corner
• 00846468084912: Fortilink-TS IBF System Trial Spacer, 17mm (H), 32mm (L)
• 00846468084905: Fortilink-TS IBF System Trial Spacer, 16mm (H), 32mm (L)
• 00846468084899: Fortilink-TS IBF System Trial Spacer, 15mm (H), 32mm (L)
• 00846468084882: Fortilink-TS IBF System Trial Spacer, 14mm (H), 32mm (L)
• 00846468084875: Fortilink-TS IBF System Trial Spacer, 13mm (H), 32mm (L)
• 00846468084868: Fortilink-TS IBF System Trial Spacer, 12mm (H), 32mm (L)
• 00846468084851: Fortilink-TS IBF System Trial Spacer, 11mm (H), 32mm (L)
• 00846468084844: Fortilink-TS IBF System Trial Spacer, 10mm (H), 32mm (L)
• 00846468084837: Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L), 6° Lordosis
• 00846468084820: Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L), 6° Lordosis
• 00846468084813: Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L), 6° Lordosis
• 00846468084806: Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L), 6° Lordosis
• 00846468084790: Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L), 6° Lordosis
• 00846468084783: Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L), 6° Lordosis
• 00846468084776: Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L), 6° Lordosis
• 00846468084769: Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L), 6° Lordosis
• 00846468084752: Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L), 6° Lordosis
• 00846468084745: Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L), 6° Lordosis
• 00846468084738: Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L)
• 00846468084721: Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L)
• 00846468084714: Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L)
• 00846468084707: Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L)
• 00846468084691: Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L)
• 00846468084684: Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L)
• 00846468084677: Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L)
• 00846468084660: Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L)
• 00846468084653: Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L)
• 00846468084646: Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L)
• 00846468084639: Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L), 6° Lordosis
• 00846468084622: Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L), 6° Lordosis
• 00846468084615: Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L), 6° Lordosis
• 00846468084608: Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L), 6° Lordosis
• 00846468084592: Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L), 6° Lordosis
• 00846468084585: Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L), 6° Lordosis
• 00846468084578: Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L), 6° Lordosis
• 00846468084561: Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L), 6° Lordosis
• 00846468084554: Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L), 6° Lordosis
• 00846468084547: Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L), 6° Lordosis
• 00846468084530: Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L)
• 00846468084523: Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L)
• 00846468084516: Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L)
• 00846468084509: Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L)
• 00846468084493: Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L)
• 00846468084486: Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L)
• 00846468084479: Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L)
• 00846468084462: Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L)
• 00846468084455: Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L)
• 00846468084448: Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L)