T-PLUS™* PEEK VBR/IBF SYSTEM 30-T-1036-8

GUDID 00846468032821

T-Plus, 10X36X8

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468032821
• NIH Device Record Key: fe1e1d33-25ae-4d72-a4cf-7f20e83acf0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-PLUS™* PEEK VBR/IBF SYSTEM
• Version Model Number: 30-T-1036-8
• Catalog Number: 30-T-1036-8
• 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(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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00846468032821 [Primary]
GS1	00846468088514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-16

On-Brand Devices [T-PLUS™* PEEK VBR/IBF SYSTEM]

• 00846468033026: T-Plus, 10X27X9, 6 DEG LORDOTIC
• 00846468033002: T-Plus, 10X27X8, 6 DEG LORDOTIC
• 00846468032982: T-Plus, 10X27X7, 6 DEG LORDOTIC
• 00846468032968: T-Plus, 10X27X15, 6 DEG LORDOTIC
• 00846468032944: T-Plus, 10X27X14, 6 DEG LORDOTIC
• 00846468032920: T-Plus, 10X27X13, 6 DEG LORDOTIC
• 00846468032906: T-Plus, 10X27X12, 6 DEG LORDOTIC
• 00846468032883: T-Plus, 10X27X11, 6 DEG LORDOTIC
• 00846468032852: T-Plus, 10X36X9, 6 DEG LORDOTIC
• 00846468032845: T-Plus, 10X36X9
• 00846468032838: T-Plus, 10X36X8, 6 DEG LORDOTIC
• 00846468032821: T-Plus, 10X36X8
• 00846468032814: T-Plus, 10X36X7
• 00846468032807: T-Plus, 10X36X15, 6 DEG LORDOTIC
• 00846468032791: T-Plus, 10X36X15
• 00846468032784: T-Plus, 10X36X14, 6 DEG LORDOTIC
• 00846468032777: T-Plus, 10X36X14
• 00846468032760: T-Plus, 10X36X13, 6 DEG LORDOTIC
• 00846468032753: T-Plus, 10X36X13
• 00846468032746: T-Plus, 10X36X12, 6 DEG LORDOTIC
• 00846468032739: T-Plus, 10X36X12
• 00846468032722: T-Plus, 10X36X11, 6 DEG LORDOTIC
• 00846468032715: T-Plus, 10X36X11
• 00846468032708: T-Plus, 10X36X10, 6 DEG LORDOTIC
• 00846468032692: T-Plus, 10X36X10
• 00846468032678: T-Plus, 10X27X9
• 00846468032654: T-Plus, 10X27X8
• 00846468032630: T-Plus, 10X27X7
• 00846468032616: T-Plus, 10X27X15
• 00846468032593: T-Plus, 10X27X14
• 00846468032586: HA T-PLUS, 10 (W) x 27 (L) x 13 (H)
• 00846468032579: T-Plus, 10X27X13
• 00846468032555: T-Plus, 10X27X12
• 00846468032531: T-Plus, 10X27X11
• 00846468032517: T-Plus, 10X27X10