ZERO Profile Interlocking Cortex Screw, 3.5mm x 58mm, T15, Flex-Thread™

GUDID 00840118117043

Intramedullary fixation rod and accessories

FLOWER ORTHOPEDICS CORPORATION

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840118117043
• NIH Device Record Key: a960dea7-bf15-4deb-90ca-b2cb6c6b5d3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERO Profile Interlocking Cortex Screw, 3.5mm x 58mm, T15, Flex-Thread™
• Version Model Number: 8525-58-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 Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118117043 [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

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