EVOS Cabling System 72580000

GUDID 00191083003979

Cable Stainless Steel w/Crimp

Pioneer Surgical Technology, Inc.

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable

• Primary Device ID: 00191083003979
• NIH Device Record Key: d619d374-1fcf-4178-925c-27ff348f930c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOS Cabling System
• Version Model Number: 56-72580000
• Catalog Number: 72580000
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(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(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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083003979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201497

FDA Product Code

• JDQ: Cerclage, fixation

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: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [EVOS Cabling System]

• 00191083004013: Cable Instrument Tray Lid
• 00191083004006: Cable Instrument Tray
• 00191083003993: Cable Crimper
• 00191083003986: Cable Tensioner Nose Cone
• 00191083003979: Cable Stainless Steel w/Crimp
• 00191083003962: Scissor Cutter
• 00191083003955: Cable Flush Cutter
• 00191083003948: Provisional Cable Tensioner
• 00191083003931: Cable Tensioner
• 00191083003924: Angled Cable Passer, 60mm
• 00191083003917: Angled Cable Passer, 50mm
• 00191083003900: Angled Cable Passer, 40mm
• 00191083003894: Straight Cable Passer, 60mm
• 00191083003887: Straight Cable Passer, 50mm
• 00191083003870: Straight Cable Passer, 40mm
• 00191083003863: Curved Cable Passer, 60mm
• 00191083003856: Curved Cable Passer, 50mm
• 00191083003849: Curved Cable Passer, 40mm