Cross-Fuse® II PEEK VBR/IBF System 38-2245-15-18L

GUDID 00846468059378

INTERBODY FUSION DEVICE / VERTEBRAL SPACER

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468059378
• NIH Device Record Key: b70b72b2-abb7-4902-872f-42f6c1bc9532
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cross-Fuse® II PEEK VBR/IBF System
• Version Model Number: 38-2245-15-18L
• Catalog Number: 38-2245-15-18L
• 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(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	00846468059378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133455

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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: 2016-09-30

On-Brand Devices [Cross-Fuse® II PEEK VBR/IBF System]

• 00846468083854: ANGLED INSERTER
• 00846468080846: Angled Inserter
• 00846468077938: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077921: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077914: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077907: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077891: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077884: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468077877: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468062668: Inserter
• 00846468062644: TRIAL SPACER
• 00846468062637: TRIAL SPACER
• 00846468062620: TRIAL SPACER
• 00846468062613: TRIAL SPACER
• 00846468062606: TRIAL SPACER
• 00846468062590: TRIAL SPACER
• 00846468062583: TRIAL SPACER
• 00846468062576: TRIAL SPACER
• 00846468062569: TRIAL SPACER
• 00846468062552: TRIAL SPACER
• 00846468062545: TRIAL SPACER
• 00846468062538: TRIAL SPACER
• 00846468062521: TRIAL SPACER
• 00846468062514: TRIAL SPACER
• 00846468062507: TRIAL SPACER
• 00846468062491: TRIAL SPACER
• 00846468062484: TRIAL SPACER
• 00846468062477: TRIAL SPACER
• 00846468062460: TRIAL SPACER
• 00846468062453: TRIAL SPACER
• 00846468062446: TRIAL SPACER
• 00846468062439: TRIAL SPACER
• 00846468062422: TRIAL SPACER
• 00846468062415: TRIAL SPACER
• 00846468062408: TRIAL SPACER
• 00846468062392: TRIAL SPACER
• 00846468062385: TRIAL SPACER
• 00846468062378: TRIAL SPACER
• 00846468062361: TRIAL SPACER
• 00846468062354: TRIAL SPACER
• 00846468062347: TRIAL SPACER
• 00846468062330: TRIAL SPACER
• 00846468062323: TRIAL SPACER
• 00846468062316: TRIAL SPACER
• 00846468061869: IMPLANT FORK
• 00846468061128: INSERTER
• 00846468059996: TRIAL SPACER
• 00846468059989: TRIAL SPACER
• 00846468059972: TRIAL SPACER
• 00846468059965: TRIAL SPACER