AccessGUDID - DEVICE: Fortilink-TS IBF System with TETRAfuse 3D Technology (00846468084080)

GUDID

Device Identifier (DI) Information

Brand Name: Fortilink-TS IBF System with TETRAfuse 3D Technology
Version or Model: 65-TS-12-32
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 65-TS-12-32
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468084080
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 32mm (L)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38161	Metallic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral fusion device with bone graft, lumbar
ODP	Intervertebral fusion device with bone graft, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12mm (H), 32mm (L)

Device Record Status

Public Device Record Key: 0384f3e3-15b1-479e-a999-61773f579064
Public Version Date: July 14, 2025
Public Version Number: 7
DI Record Publish Date: October 30, 2017