Cross-Fuse PEEK IBF System 35-1860-13

GUDID 00846468035587

Crossfuse, 13x18x60x0 spacer

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468035587
• NIH Device Record Key: cd916379-6bec-4dea-98e0-b4d290a18e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cross-Fuse PEEK IBF System
• Version Model Number: 35-1860-13
• Catalog Number: 35-1860-13
• 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
• 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
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083029481 [Primary]
GS1	00846468035587 [Primary]
GS1	00846468038144 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623
• Premarket Notification: K170643

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: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Cross-Fuse PEEK IBF System]

• 00846468092641: VBR, Crossfuse, 13x18x55x6 spacer
• 00846468041090: TRIAL CADDY
• 00846468041083: TAMP
• 00846468041069: INSERTER, MODULAR CLEANING
• 00846468040987: INSERTER, MODULAR CLEANING
• 00846468040963: TRIAL SPACER
• 00846468039318: TRIAL SPACER
• 00846468039301: TRIAL SPACER
• 00846468039288: TRIAL SPACER
• 00846468039134: TRIAL SPACER
• 00846468039066: TRIAL SPACER
• 00846468039059: TRIAL SPACER
• 00846468039042: TRIAL SPACER
• 00846468039028: TRIAL SPACER
• 00846468039011: TRIAL SPACER
• 00846468035945: TRIAL SPACER
• 00846468035938: TRIAL SPACER
• 00846468035914: TRIAL SPACER
• 00846468035891: 22X55X9MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468035884: 22X55X9MM CROSSFUSE IMPLANTS
• 00846468035846: 22X55X13MM CROSSFUSE IMPLANTS
• 00846468035822: 22X55X11MM CROSSFUSE IMPLANTS
• 00846468035815: 22X50X9MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468035778: 22X50X13MM 6 DEGREE CROSSFUSE IMPLANTS
• 00846468035761: 22X50X13MM CROSSFUSE IMPLANTS
• 00846468035723: 22X45X9MM CROSSFUSE IMPLANTS
• 00846468035716: 22X45X15MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468035693: 22X45X13MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468035679: 22X45X11MM 6DEGREE CROSSFUSE IMPLANTS
• 00846468035662: 22X45X11MM CROSSFUSE IMPLANTS
• 00846468035631: Crossfuse, 17x18x60x6 spacer
• 00846468035617: Crossfuse, 15x18x60x6 spacer
• 00846468035594: Crossfuse, 13x18x60x6 spacer
• 00846468035587: Crossfuse, 13x18x60x0 spacer
• 00846468035549: VBR, Crossfuse, 9x18x55x0 spacer
• 00846468035525: VBR, Crossfuse, 17x18x55x0 spacer
• 00846468035518: VBR, Crossfuse, 15x18x55x6 spacer
• 00846468035464: VBR, Crossfuse, 11x18x55x0 spacer
• 00846468035440: VBR, Crossfuse, 9x18x50x0 spacer
• 00846468035433: VBR, Crossfuse, 17x18x50x6 spacer
• 00846468035402: VBR, Crossfuse, 15x18x50x0 spacer
• 00846468035365: VBR, Crossfuse, 13x18x50x0 spacer
• 00846468035341: VBR, Crossfuse, 11x18x50x6 spacer
• 00846468035273: VBR, Crossfuse, 11x18x50x0 spacer
• 00846468035235: VBR, Crossfuse, 9x18x45x0 spacer
• 00846468035228: VBR, Crossfuse, 15x18x45x6 spacer
• 00846468035174: VBR, Crossfuse, 13x18x45x6 spacer
• 00846468035129: 35-1845-11-6se, 11x18x45x0 spacer
• 00846468035112: VBR, Crossfuse, 9x18x40x0 spacer
• 00846468035082: VBR, Crossfuse, 13x18x40x0 spacer