Flow-Screw 45-2010

GUDID B2674520100

4.5/10mm FT Flow-Screw

Flow-FX

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B2674520100
• NIH Device Record Key: d5a64400-6649-4a49-bd72-b209038cf624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Screw
• Version Model Number: 45-2010
• Catalog Number: 45-2010
• Company DUNS: 079293587
• Company Name: Flow-FX
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2674520100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142776

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B2674520100]

Moist Heat or Steam Sterilization

[B2674520100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-23
• Device Publish Date: 2018-06-22

Devices Manufactured by Flow-FX

• B26710230050 - Flow-Screw™: 2024-09-06 2.7mm Unthreaded Guidewire
• B26710216000 - Flow-Screw™: 2024-07-30 FS Short Driver 4.5mm
• B2675510700 - Flow-Screw™: 2024-07-30 5.5/70mm Flow-Screw Partial Thread Long
• B2675520750 - Flow-Screw™: 2024-07-30 5.5/75mm FT Flow-Screw
• B2672CAN350B0 - 2-CAN™: 2024-03-25 2-CAN™ 350mm Delivery Cannula
• B2672CAN450B0 - 2-CAN™: 2023-07-17 2-CAN™ 450mm Delivery Cannula
• B26711036K0 - Flow-Drill™: 2022-11-28 Flow-Drill 3.6mm Kit
• B26711048K0 - Flow-Drill™: 2022-11-28 Flow-Drill 4.8mm Kit