Fortilink-TS IBF System 65-TS-TRL22-17-6L

GUDID 00846468084639

Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L), 6° Lordosis

Pioneer Surgical Technology, Inc.

Surgical implant template, reusable
Primary Device ID00846468084639
NIH Device Record Key988c1ae2-06ed-4bde-b5d6-037b6bd3126b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortilink-TS IBF System
Version Model Number65-TS-TRL22-17-6L
Catalog Number65-TS-TRL22-17-6L
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100846468084639 [Primary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


[00846468084639]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-26
Device Publish Date2017-10-30

On-Brand Devices [Fortilink-TS IBF System]

00846468086503Fortilink-TS IBF System Instrument Case
00846468084981Fortilink-TS IBF System Tamp, Corner
00846468084912Fortilink-TS IBF System Trial Spacer, 17mm (H), 32mm (L)
00846468084905Fortilink-TS IBF System Trial Spacer, 16mm (H), 32mm (L)
00846468084899Fortilink-TS IBF System Trial Spacer, 15mm (H), 32mm (L)
00846468084882Fortilink-TS IBF System Trial Spacer, 14mm (H), 32mm (L)
00846468084875Fortilink-TS IBF System Trial Spacer, 13mm (H), 32mm (L)
00846468084868Fortilink-TS IBF System Trial Spacer, 12mm (H), 32mm (L)
00846468084851Fortilink-TS IBF System Trial Spacer, 11mm (H), 32mm (L)
00846468084844Fortilink-TS IBF System Trial Spacer, 10mm (H), 32mm (L)
00846468084837Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L), 6° Lordosis
00846468084820Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L), 6° Lordosis
00846468084813Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L), 6° Lordosis
00846468084806Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L), 6° Lordosis
00846468084790Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L), 6° Lordosis
00846468084783Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L), 6° Lordosis
00846468084776Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L), 6° Lordosis
00846468084769Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L), 6° Lordosis
00846468084752Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L), 6° Lordosis
00846468084745Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L), 6° Lordosis
00846468084738Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L)
00846468084721Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L)
00846468084714Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L)
00846468084707Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L)
00846468084691Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L)
00846468084684Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L)
00846468084677Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L)
00846468084660Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L)
00846468084653Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L)
00846468084646Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L)
00846468084639Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L), 6° Lordosis
00846468084622Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L), 6° Lordosis
00846468084615Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L), 6° Lordosis
00846468084608Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L), 6° Lordosis
00846468084592Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L), 6° Lordosis
00846468084585Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L), 6° Lordosis
00846468084578Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L), 6° Lordosis
00846468084561Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L), 6° Lordosis
00846468084554Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L), 6° Lordosis
00846468084547Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L), 6° Lordosis
00846468084530Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L)
00846468084523Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L)
00846468084516Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L)
00846468084509Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L)
00846468084493Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L)
00846468084486Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L)
00846468084479Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L)
00846468084462Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L)
00846468084455Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L)
00846468084448Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.