Osteo Screw Washer

GUDID 00840118106603

implant for orthopedic bone fixation, compatible with 3.5mm/4.0mm/4.5mm screws

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone washer, sterile

• Primary Device ID: 00840118106603
• NIH Device Record Key: fed6579b-d5fd-4a74-b62a-8613b140b5ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteo Screw Washer
• Version Model Number: OSW 100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118106603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132248

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2015-09-22

On-Brand Devices [Osteo Screw Washer]

• 00840118106610: implant for orthopedic bone fixation, compatible with 5.5mm/6.5mm/7.3mm screws
• 00840118106603: implant for orthopedic bone fixation, compatible with 3.5mm/4.0mm/4.5mm screws