Fortilink-A IBF System 65-A-L14-20L

GUDID 00846468093990

Interbody Fusion Device

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis
Primary Device ID00846468093990
NIH Device Record Key6edb726b-3a5f-4d76-9ce4-1aaf85026b2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortilink-A IBF System
Version Model Number65-A-L14-20L
Catalog Number65-A-L14-20L
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100846468093990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2020-01-10

On-Brand Devices [Fortilink-A IBF System]

00846468098414V Shape Tamp
00846468094010Interbody Fusion Device
00846468094003Interbody Fusion Device
00846468093990Interbody Fusion Device
00846468093983Interbody Fusion Device
00846468093976Interbody Fusion Device
00846468093969Interbody Fusion Device
00846468093952Interbody Fusion Device
00846468093945Interbody Fusion Device
00846468093938Interbody Fusion Device
00846468093921Interbody Fusion Device
00846468093914Interbody Fusion Device
00846468093907Interbody Fusion Device
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