Fortilink-A IBF System

Basic Information

• Brand Name: Fortilink-A IBF System
• Primary DI: 00846468093907
• Version / Model: 65-A-S12-20L
• Catalog Number: 65-A-S12-20L
• Company Name: Pioneer Surgical Technology, Inc.
• Labeler DUNS: 793384496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-10
• Public Version: 3
• Public Version Date: 2021-10-14
• Public Version Status: Update
• Public Device Record Key: a9e23692-0841-436f-9b8f-5ba9955792f5

Device Description

Interbody Fusion Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34170	Vertebral body prosthesis	An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846468093907	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192718	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			32mm (W)25mm (D)12mm (H)20 (L)