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

• 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