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

GUDID 00846468088705

INTERBODY FUSION DEVICE

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468088705
• NIH Device Record Key: 3db64cc5-0f44-4957-8284-e0f450744172
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Plus PEEK IBF System
• Version Model Number: 30-T-10-6
• Catalog Number: 30-T-10-6
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468088705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

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

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