Cross-Fuse PEEK IBF System 35-1450-13

GUDID 00846468034337

.VBR, Crossfuse, 13x14x50x0 spacer

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis
Primary Device ID00846468034337
NIH Device Record Key12081534-6148-4c04-9b7f-1d857a4ebaac
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross-Fuse PEEK IBF System
Version Model Number35-1450-13
Catalog Number35-1450-13
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
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(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468034337 [Primary]
GS100846468037659 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

On-Brand Devices [Cross-Fuse PEEK IBF System]

00846468092641VBR, Crossfuse, 13x18x55x6 spacer
00846468041090TRIAL CADDY
00846468041083TAMP
00846468041069INSERTER, MODULAR CLEANING
00846468040987INSERTER, MODULAR CLEANING
00846468040963TRIAL SPACER
00846468039318TRIAL SPACER
00846468039301TRIAL SPACER
00846468039288TRIAL SPACER
00846468039134TRIAL SPACER
00846468039066TRIAL SPACER
00846468039059TRIAL SPACER
00846468039042TRIAL SPACER
00846468039028TRIAL SPACER
00846468039011TRIAL SPACER
00846468035945TRIAL SPACER
00846468035938TRIAL SPACER
00846468035914TRIAL SPACER
0084646803589122X55X9MM 6 DEGREE CROSSFUSE IMPLANTS
0084646803588422X55X9MM CROSSFUSE IMPLANTS
0084646803584622X55X13MM CROSSFUSE IMPLANTS
0084646803582222X55X11MM CROSSFUSE IMPLANTS
0084646803581522X50X9MM 6 DEGREE CROSSFUSE IMPLANTS
0084646803577822X50X13MM 6 DEGREE CROSSFUSE IMPLANTS
0084646803576122X50X13MM CROSSFUSE IMPLANTS
0084646803572322X45X9MM CROSSFUSE IMPLANTS
0084646803571622X45X15MM 6DEGREE CROSSFUSE IMPLANTS
0084646803569322X45X13MM 6DEGREE CROSSFUSE IMPLANTS
0084646803567922X45X11MM 6DEGREE CROSSFUSE IMPLANTS
0084646803566222X45X11MM CROSSFUSE IMPLANTS
00846468035631Crossfuse, 17x18x60x6 spacer
00846468035617Crossfuse, 15x18x60x6 spacer
00846468035594Crossfuse, 13x18x60x6 spacer
00846468035587Crossfuse, 13x18x60x0 spacer
00846468035549VBR, Crossfuse, 9x18x55x0 spacer
00846468035525VBR, Crossfuse, 17x18x55x0 spacer
00846468035518VBR, Crossfuse, 15x18x55x6 spacer
00846468035464VBR, Crossfuse, 11x18x55x0 spacer
00846468035440VBR, Crossfuse, 9x18x50x0 spacer
00846468035433VBR, Crossfuse, 17x18x50x6 spacer
00846468035402VBR, Crossfuse, 15x18x50x0 spacer
00846468035365VBR, Crossfuse, 13x18x50x0 spacer
00846468035341VBR, Crossfuse, 11x18x50x6 spacer
00846468035273VBR, Crossfuse, 11x18x50x0 spacer
00846468035235VBR, Crossfuse, 9x18x45x0 spacer
00846468035228VBR, Crossfuse, 15x18x45x6 spacer
00846468035174VBR, Crossfuse, 13x18x45x6 spacer
0084646803512935-1845-11-6se, 11x18x45x0 spacer
00846468035112VBR, Crossfuse, 9x18x40x0 spacer
00846468035082VBR, Crossfuse, 13x18x40x0 spacer

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