FlowerRope

GUDID 00840118115971

A Knotless Fixation Band System For Syndesmotic Fixation

FLOWER ORTHOPEDICS CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00840118115971
• NIH Device Record Key: 2e3acad5-07c1-4fae-9b17-4d7a4c2441b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowerRope
• Version Model Number: DLF 001
• 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

Device Dimensions

• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118115971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150359

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2020-03-23
• Device Publish Date: 2020-03-13

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

• 00840118124133 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 4.5mm x 55mm
• 00840118124461 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 6.5mm x 70mm
• 00840118124508 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 6.5mm x 90mm
• 00840118124683 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 55mm
• 00840118124768 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 95mm
• 00840118124836 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 130mm
• 00840118124102 - Flower Orthopedics: 2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 40mm
• 00840118124119 - Flower Orthopedics: 2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 45mm