CONTACT™* IBF PEEK VBR/IBF SYSTEM 34-A36-18-12

GUDID 00846468036300

INTERBODY FUSION DEVICE / VERTEBRAL SPACER

Pioneer Surgical Technology, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00846468036300
• NIH Device Record Key: f02ed9e5-fb84-4e3c-bbe2-5fb90acca3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTACT™* IBF PEEK VBR/IBF SYSTEM
• Version Model Number: 34-A36-18-12
• Catalog Number: 34-A36-18-12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468036300 [Primary]
GS1	00846468091231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133455

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-25

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

• 00846468036508: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036492: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036485: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036478: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036461: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036454: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036447: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036430: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036423: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036416: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036409: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036393: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036386: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036379: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036362: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036355: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036348: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036331: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036324: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036317: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036300: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036294: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036287: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036270: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036263: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036256: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036249: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036232: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036225: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036218: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036201: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036195: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036171: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036164: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036157: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036133: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036126: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036119: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036096: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036089: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036072: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036058: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036041: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036034: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036010: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036003: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468035990: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468035976: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468035969: INTERBODY FUSION DEVICE / VERTEBRAL SPACER