Locking Screw, XL, D: 2.4mm x L:16mm

GUDID 00840118112147

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118112147
• NIH Device Record Key: 4a016ad0-0b9f-4df1-8da8-e2200ea2f6b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Screw, XL, D: 2.4mm x L:16mm
• Version Model Number: FRS 916
• 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

Device Dimensions

• Outer Diameter: 2.4 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118112147 [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: 2017-03-21

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