T-Plus PEEK IBF System 30-T-10-6

GUDID 00846468088705

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
Primary Device ID00846468088705
NIH Device Record Key3db64cc5-0f44-4957-8284-e0f450744172
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Plus PEEK IBF System
Version Model Number30-T-10-6
Catalog Number30-T-10-6
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

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]
GS100846468088705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical
ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [T-Plus PEEK IBF System]

00846468033521TRIAL SPACER
00846468033491TRIAL SPACER
00846468033460TRIAL SPACER
00846468033439TRIAL SPACER
00846468033408TRIAL SPACER
00846468033378TRIAL SPACER
00846468033347TRIAL SPACER
00846468033316TRIAL SPACER
00846468033286TRIAL SPACER
00846468033279TRIAL SPACER
00846468033262TRIAL SPACER
00846468033255TRIAL SPACER
00846468033248TRIAL SPACER
00846468033231TRIAL SPACER
00846468033224TRIAL SPACER
00846468033217TRIAL SPACER
00846468033200TRIAL SPACER
00846468033194TRIAL SPACER
00846468033156CRESCENT TAMP
00846468033149SLAP HAMMER
00846468033101INSERTER
00846468062743Tricortical Cancellous Wedge Inserter with Stop
00846468062736Tricortical Cancellous Wedge Inserter
00846468011093TRIAL SPACER, STRAIGHT
00846468009205LONG TRIAL SPACER
00846468009113TRIAL SPACER, STRAIGHT
00846468009083LONG TRIAL SPACER
00846468008994TRIAL SPACER, STRAIGHT
00846468008963LONG TRIAL SPACER
00846468008901TRIAL SPACER, STRAIGHT
00846468008840LONG TRIAL SPACER
00846468008789TRIAL SPACER, STRAIGHT
00846468008758LONG TRIAL SPACER
00846468008680TRIAL SPACER, STRAIGHT
00846468008659LONG TRIAL SPACER
00846468008345TRIAL SPACER, STRAIGHT
00846468008314LONG TRIAL SPACER
00846468008253TRIAL SPACER, STRAIGHT
00846468008192LONG TRIAL SPACER
00846468008130TRIAL SPACER, STRAIGHT
00846468008109LONG TRIAL SPACER
00846468007720LONG STRAIGHT TAMP
00846468007515LONG "L" TAMP
00846468007478LONG CRESCENT TAMP
00846468007386STRAIGHT INSERTER
00846468007348LONG INSERTER
00846468007317INSERTER, MODULAR CLEANING
00191083025711VBR, T+ Pistol Grip Inserter Assembly
00191083025674T-Plus Straight Inserter Special
00846468088705INTERBODY FUSION DEVICE

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