Cannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™

GUDID 00840118117425

Intramedullary fixation rod and accessories

FLOWER ORTHOPEDICS CORPORATION

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840118117425
• NIH Device Record Key: d8099822-0301-4256-af59-473de9286826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™
• Version Model Number: 8527-1-S
• Company DUNS: 078790947
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• 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(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com
• Phone: +1(877)778-8587
• Email: info@flowerortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118117425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202858

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 2021-03-29
• Device Publish Date: 2021-03-19

On-Brand Devices [Cannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™]

• 00840118117678: Intramedullary fixation rod and accessories
• 00840118117425: Intramedullary fixation rod and accessories