Variable Angle Non-Locking Screw

GUDID 00840118104791

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118104791
• NIH Device Record Key: f40fef32-869c-4f6b-b628-e087c8ebfde2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Angle Non-Locking Screw
• Version Model Number: FLS 316
• 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: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118104791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123562

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-15

On-Brand Devices [Variable Angle Non-Locking Screw]

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• 00840118109833: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109826: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118109819: Implants for orthopedic bone fixation. Also Called a Bone Screw.
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• 00840118104494: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118104487: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101837: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101820: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101813: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101806: Implants for orthopedic bone fixation. Also Called a Bone Screw.
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• 00840118101783: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101776: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101769: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101752: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101745: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101738: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101721: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101714: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101707: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101691: Implants for orthopedic bone fixation. Also Called a Bone Screw.
• 00840118101684: Implants for orthopedic bone fixation. Also Called a Bone Screw.