2.0mm Straight Osteo Plate, 4 Holes,1.5mm/2.0mm/2.4mm

GUDID 00840118101110

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00840118101110
• NIH Device Record Key: 42bc2d83-f44a-4ea5-9d09-806e75d86268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0mm Straight Osteo Plate, 4 Holes,1.5mm/2.0mm/2.4mm
• Version Model Number: FHF 371
• 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
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com

Device Dimensions

• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118101110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131657

FDA Product Code

• HRS: Plate, 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-04

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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• 00840118126298 - Active Compression: 2025-12-09 Small Hudson Adaptor
• 00840118126526 - Active Compression: 2025-12-09 7.0mm x 120mm Active Compression Implant
• 00840118125802 - Flower Orthopedics: 2025-04-21 Trephine Cannula
• 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