K-Wires, 1.1mm x 22, Flex-Thread™

GUDID 00840118118354

Intramedullary fixation rod and accessories

FLOWER ORTHOPEDICS CORPORATION

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840118118354
• NIH Device Record Key: 798370d6-5c5e-4ab9-b284-a27cc98bc071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wires, 1.1mm x 22, Flex-Thread™
• Version Model Number: 8808-1-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: 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(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 Dimensions

• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 1.1 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118118354 [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: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [K-Wires, 1.1mm x 22, Flex-Thread™]

• 00840118118361: Intramedullary fixation rod and accessories
• 00840118118354: Intramedullary fixation rod and accessories