AccessGUDID - DEVICE: Fortilink-L IBF System (00191083007946)

GUDID

Device Identifier (DI) Information

Brand Name: Fortilink-L IBF System
Version or Model: 65-L-2255-11-6L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 65-L-2255-11-6L
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00191083007946
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use
Previous DI: 00846468085988

Device Description: Interbody Fusion Device

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60762	Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.	Active	true

FDA Product Code

[?]

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

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: 22mm (W), 55mm (L), 11mm (H), 6 degrees Lordosis

Device Record Status

Public Device Record Key: e428f205-e78f-4555-9e24-3d6cf4096e19
Public Version Date: February 28, 2025
Public Version Number: 7
DI Record Publish Date: February 08, 2021