Headless Compression Screw, D:2.4mm x L: 28mm

GUDID 00840118112529

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118112529
• NIH Device Record Key: f618f7ca-c599-4f97-ad3b-8a9db9097a95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headless Compression Screw, D:2.4mm x L: 28mm
• Version Model Number: HCS 128
• 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: 28 Millimeter
• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118112529 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-19

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

• 00840118124096 - Flower Orthopedics: 2025-02-06 OsteoCoil Nitinol Compression System- 4.5mm x 35mm
• 00840118124539 - Flower Orthopedics: 2025-02-06 OsteoCoil Nitinol Compression System- 6.5mm x 105mm
• 00840118124690 - Flower Orthopedics: 2025-02-06 OsteoCoil Nitinol Compression System- 7.3mm x 60mm
• 00840118124089 - Flower Orthopedics: 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 30mm
• 00840118124126 - Flower Orthopedics: 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 50mm
• 00840118124140 - Flower Orthopedics: 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 60mm
• 00840118124188 - Flower Orthopedics: 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 80mm
• 00840118124195 - Flower Orthopedics: 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 85mm