2.0mm Recon Plate, 10 Holes, 1.5mm/2.0mm/2.4mm

GUDID 00840118102780

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00840118102780
• NIH Device Record Key: 8ecf2046-6d23-40df-bb96-050c47ea7db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0mm Recon Plate, 10 Holes, 1.5mm/2.0mm/2.4mm
• Version Model Number: FHF 910
• 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

Device Dimensions

• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter
• Height: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118102780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123562

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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• 00840118125024 - Flower Orthopedics: 2024-06-10 Flower K-Wire S, 0.8mm, sterile, single use (2 pieces)
• 00840118125031 - Flower Orthopedics: 2024-06-10 Flower Drill Guide S, D:1.5mm, sterile, single use
• 00840118125055 - Flower Orthopedics: 2024-06-10 Flower Torque Bit S, sterile, single use
• 00840118125062 - Flower Orthopedics: 2024-06-10 Flower K-Wire XS, 0.6mm, sterile, single use (2 pieces)
• 00840118125079 - Flower Orthopedics: 2024-06-10 Flower Drill S, D:1.5mm, sterile, single use
• 00840118125086 - Flower Orthopedics: 2024-06-10 Flower K-Wire Applicator, sterile
• 00840118125093 - Flower Orthopedics: 2024-06-10 Flower Peek K-Wire Applicator (PWA), sterile