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
| B2672CAN3500 - 2-CAN™ | 2025-07-21 2-CAN™ 350mm Delivery Cannula |
| 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 |
Trademark Results [Flow-Screw]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOW-SCREW 85681465 4951568 Live/Registered |
Orthopedic Generations LLC 2012-07-19 |
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