Lag Screw, Partially Threaded

GUDID 00840118108409

implant for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118108409
• NIH Device Record Key: 7d666f81-2c1a-4343-9244-883ac9d19b75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lag Screw, Partially Threaded
• Version Model Number: LSP 435
• 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

• Length: 35 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118108409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132248

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: 2015-09-22

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• 00840118108089: implant for orthopedic bone fixation