Variable Angle Locking Screw, Low Profile, D:2.7mm x L:55.0mm

GUDID 00840118100557

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118100557
• NIH Device Record Key: eb35b5dd-b499-41db-ab63-2838f2c1066c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variable Angle Locking Screw, Low Profile, D:2.7mm x L:55.0mm
• Version Model Number: FLP 255
• 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: 2.7 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118100557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131657

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

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