Contact PEEK IBF System 34-WINDOW40-16

GUDID 00846468037437

DISTRACTION WINDOW

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00846468037437
• NIH Device Record Key: 7176e30c-f5a8-4ca0-b3da-e02a0dba48b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contact PEEK IBF System
• Version Model Number: 34-WINDOW40-16
• Catalog Number: 34-WINDOW40-16
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468032180 [Primary]
GS1	00846468037437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133455

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

[00846468037437]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-30
• Device Publish Date: 2019-12-21

On-Brand Devices [Contact PEEK IBF System]

• 00846468037482: WINDOW INSERTER
• 00846468037475: WINDOW INSERTER
• 00846468037468: WINDOW INSERTER
• 00846468037451: DISTRACTION WINDOW
• 00846468037444: DISTRACTION WINDOW
• 00846468037437: DISTRACTION WINDOW
• 00846468037420: DISTRACTION WINDOW
• 00846468037413: DISTRACTION WINDOW
• 00846468037406: DISTRACTION WINDOW
• 00846468037390: DISTRACTION WINDOW
• 00846468037383: DISTRACTION WINDOW
• 00846468037376: DISTRACTION WINDOW
• 00846468037369: DISTRACTION WINDOW
• 00846468037352: DISTRACTION WINDOW
• 00846468037345: DISTRACTION WINDOW
• 00846468037338: DISTRACTION WINDOW
• 00846468037321: DISTRACTION WINDOW
• 00846468037314: DISTRACTION WINDOW
• 00846468037291: TRIAL SPACER
• 00846468037284: TRIAL SPACER
• 00846468037277: TRIAL SPACER
• 00846468037260: TRIAL SPACER
• 00846468037253: TRIAL SPACER
• 00846468037246: TRIAL SPACER
• 00846468037239: TRIAL SPACER
• 00846468037222: TRIAL SPACER
• 00846468037215: TRIAL SPACER
• 00846468037208: TRIAL SPACER
• 00846468037192: TRIAL SPACER
• 00846468037185: TRIAL SPACER
• 00846468037178: TRIAL SPACER
• 00846468037161: TRIAL SPACER
• 00846468037154: TRIAL SPACER
• 00846468037147: TRIAL SPACER
• 00846468037130: TRIAL SPACER
• 00846468037123: TRIAL SPACER
• 00846468037116: TRIAL SPACER
• 00846468037109: TRIAL SPACER
• 00846468037093: TRIAL SPACER
• 00846468037086: TRIAL SPACER
• 00846468037079: TRIAL SPACER
• 00846468037062: TRIAL SPACER
• 00846468037055: TRIAL SPACER
• 00846468037048: TRIAL SPACER
• 00846468037031: TRIAL SPACER
• 00846468037024: TRIAL SPACER
• 00846468037017: TRIAL SPACER
• 00846468037000: TRIAL SPACER
• 00846468036997: TRIAL SPACER
• 00846468036980: TRIAL SPACER