Fortilink-TS IBF System with TETRAfuse 3D Technology 65-TS-9-26-6L

GUDID 00846468083939

Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 26mm (L), 6° Lordosis

Pioneer Surgical Technology, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00846468083939
NIH Device Record Key49bcffd9-fcdd-43b2-b7af-b58bf5e5b5ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortilink-TS IBF System with TETRAfuse 3D Technology
Version Model Number65-TS-9-26-6L
Catalog Number65-TS-9-26-6L
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468083939 [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 Number4
Public Version Date2020-02-24
Device Publish Date2017-10-30

On-Brand Devices [Fortilink-TS IBF System with TETRAfuse 3D Technology]

00846468084332Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 32mm (
00846468084325Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 26mm (
00846468084318Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 26mm (
00846468084301Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 22mm (
00846468084295Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 17mm (H), 22mm (
00846468084288Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 32mm (
00846468084271Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 26mm (
00846468084264Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 26mm (
00846468084257Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 22mm (
00846468084240Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 16mm (H), 22mm (
00846468084233Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 32mm (
00846468084226Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 26mm (
00846468084219Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 26mm (
00846468084202Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 22mm (
00846468084196Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 15mm (H), 22mm (
00846468084189Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 32mm (
00846468084172Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 26mm (
00846468084165Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 26mm (
00846468084158Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 22mm (
00846468084141Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (H), 22mm (
00846468084134Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 32mm (
00846468084127Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 26mm (
00846468084110Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 26mm (
00846468084103Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 22mm (
00846468084097Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 13mm (H), 22mm (
00846468084080Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 32mm (
00846468084073Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 26mm (
00846468084066Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 26mm (
00846468084059Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 22mm (
00846468084042Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 12mm (H), 22mm (
00846468084035Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 32mm (
00846468084028Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 26mm (
00846468084011Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 26mm (
00846468084004Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 22mm (
00846468083991Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 22mm (
00846468083984Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 32mm (
00846468083977Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 26mm (
00846468083960Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 26mm (
00846468083953Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 22mm (
00846468083946Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 10mm (H), 22mm (
00846468083939Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 26mm (L
00846468083922Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 26mm (L
00846468083915Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 22mm (L
00846468083908Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 9mm (H), 22mm (L
00846468083892Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 26mm (L
00846468083885Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 26mm (L
00846468083878Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 22mm (L
00846468083861Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 8mm (H), 22mm (L
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.