Headless Compression Screw, D:4.0mm x L: 46mm

GUDID 00840118115155

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118115155
• NIH Device Record Key: 467bcee5-115d-4edd-a518-001f6aeb1181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headless Compression Screw, D:4.0mm x L: 46mm
• Version Model Number: HCS 446
• 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: 4 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118115155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170687

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: 2019-06-24
• Device Publish Date: 2019-06-14

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