CROSS-FUSE™* PEEK VBR/IBF SYSTEM 35-1455-15

GUDID 00846468037765

VBR, Crossfuse, 15x14x55x0 spacer

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468037765
• NIH Device Record Key: abc753a7-21d9-45a3-8aef-f6ab5964168e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSS-FUSE™* PEEK VBR/IBF SYSTEM
• Version Model Number: 35-1455-15
• Catalog Number: 35-1455-15
• 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	00846468037765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

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: 2015-12-21

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

• 00846468038458: 22X55X9MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038441: 22X55X9MM CROSSFUSE IMPLANTS
• 00846468038434: 22X55X15MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038427: 22X55X15MM CROSSFUSE IMPLANTS
• 00846468038410: 22X55X13MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038403: 22X55X13MM CROSSFUSE IMPLANTS
• 00846468038397: 22X55X11MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038380: 22X55X11MM CROSSFUSE IMPLANTS
• 00846468038373: 22X50X9MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038366: 22X50X9MM CROSSFUSE IMPLANTS
• 00846468038359: 22X50X15MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038342: 22X50X15MM CROSSFUSE IMPLANTS
• 00846468038335: 22X50X13MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038328: 22X50X13MM CROSSFUSE IMPLANTS
• 00846468038311: 22X50X11MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468038304: 22X50X11MM CROSSFUSE IMPLANTS
• 00846468038298: 22X45X9MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468038281: 22X45X9MM CROSSFUSE IMPLANTS
• 00846468038274: 22X45X15MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468038267: 22X45X15MM CROSSFUSE IMPLANTS
• 00846468038250: 22X45X13MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468038243: 22X45X13MM CROSSFUSE IMPLANTS
• 00846468038236: 22X45X11MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468038229: 22X45X11MM CROSSFUSE IMPLANTS
• 00846468038212: Crossfuse, 9x18x60x6 spacer
• 00846468038205: Crossfuse, 9x18x60x0 spacer
• 00846468038199: Crossfuse, 17x18x60x6 spacer
• 00846468038182: Crossfuse, 17x18x60x0 spacer
• 00846468038175: Crossfuse, 15x18x60x6 spacer
• 00846468038168: Crossfuse, 15x18x60x0 spacer
• 00846468038151: Crossfuse, 13x18x60x6 spacer
• 00846468038144: Crossfuse, 13x18x60x0 spacer
• 00846468038137: Crossfuse, 11x18x60x6 spacer
• 00846468038120: Crossfuse, 11x18x60x0 spacer
• 00846468038113: VBR, Crossfuse, 9x18x55x6 spacer
• 00846468038106: VBR, Crossfuse, 9x18x55x0 spacer
• 00846468038090: VBR, Crossfuse, 17x18x55x6 spacer
• 00846468038083: VBR, Crossfuse, 17x18x55x0 spacer
• 00846468038076: VBR, Crossfuse, 15x18x55x6 spacer
• 00846468038069: VBR, Crossfuse, 15x18x55x0 spacer
• 00846468038052: VBR, Crossfuse, 13x18x55x6 spacer
• 00846468038045: VBR, Crossfuse, 13x18x55x0 spacer
• 00846468038038: VBR, Crossfuse, 11x18x55x6 spacer
• 00846468038021: VBR, Crossfuse, 11x18x55x0 spacer
• 00846468038014: VBR, Crossfuse, 9x18x50x6 spacer
• 00846468038007: VBR, Crossfuse, 9x18x50x0 spacer
• 00846468037994: VBR, Crossfuse, 17x18x50x6 spacer
• 00846468037987: VBR, Crossfuse, 17x18x50x0 spacer
• 00846468037970: VBR, Crossfuse, 15x18x50x6 spacer
• 00846468037963: VBR, Crossfuse, 15x18x50x0 spacer