Variable Angle Compression Screw

GUDID 00840118114578

Implants for orthopedic bone fixation.

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118114578
• NIH Device Record Key: 64283020-a574-45ae-bd41-dd4c07b24e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Angle Compression Screw
• Version Model Number: FCS 430
• 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: 2.4 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118114578 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-11-28

On-Brand Devices [Variable Angle Compression Screw]

• 00840118114578: Implants for orthopedic bone fixation.
• 00840118114561: Implants for orthopedic bone fixation.
• 00840118114554: Implants for orthopedic bone fixation.
• 00840118114547: Implants for orthopedic bone fixation.
• 00840118111560: Implants for orthopedic bone fixation.
• 00840118111553: Implants for orthopedic bone fixation.
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• 00840118111539: Implants for orthopedic bone fixation.
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• 00840118111485: implants for orthopedic bone fixation
• 00840118111478: implants for orthopedic bone fixation
• 00840118111461: implants for orthopedic bone fixation
• 00840118111454: implants for orthopedic bone fixation
• 00840118111447: implants for orthopedic bone fixation
• 00840118111430: implants for orthopedic bone fixation
• 00840118111423: implants for orthopedic bone fixation
• 00840118111416: implants for orthopedic bone fixation
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• 00840118111355: implants for orthopedic bone fixation
• 00840118111348: Implants for orthopedic bone fixation.
• 00840118111331: Implants for orthopedic bone fixation.
• 00840118111324: Implants for orthopedic bone fixation.
• 00840118110945: Implants for orthopedic bone fixation.
• 00840118110938: Implants for orthopedic bone fixation.
• 00840118110921: Implants for orthopedic bone fixation.
• 00840118110914: Implants for orthopedic bone fixation.
• 00840118110907: Implants for orthopedic bone fixation.
• 00840118110594: Implants for orthopedic bone fixation.
• 00840118110587: Implants for orthopedic bone fixation.
• 00840118110570: Implants for orthopedic bone fixation.
• 00840118110563: Implants for orthopedic bone fixation.
• 00840118110556: Implants for orthopedic bone fixation.
• 00840118110549: Implants for orthopedic bone fixation.
• 00840118110532: Implants for orthopedic bone fixation.
• 00840118110525: Implants for orthopedic bone fixation.
• 00840118110518: Implants for orthopedic bone fixation.
• 00840118110501: Implants for orthopedic bone fixation.
• 00840118110495: Implants for orthopedic bone fixation.
• 00840118110488: Implants for orthopedic bone fixation.
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• 00840118110464: Implants for orthopedic bone fixation.
• 00840118110457: Implants for orthopedic bone fixation.
• 00840118110440: Implants for orthopedic bone fixation.
• 00840118110433: Implants for orthopedic bone fixation.