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FDA 510(k)

Flow-Nail

K-Number: K221115 · 2022-05-13

ApplicantFlow-Fx, LLC
Decision Date2022-05-13
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flow-Nail is a medical device manufactured by Flow-Fx, LLC. It received FDA 510(k) clearance on 2022-05-13 under approval number K221115. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flow-Nail?

Flow-Nail is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Flow-Fx, LLC. The 510(k) number is K221115.

When was Flow-Nail approved by the FDA?

Flow-Nail received FDA 510(k) clearance on 2022-05-13, under approval number K221115.

What company makes Flow-Nail?

Flow-Nail is manufactured by Flow-Fx, LLC.

What is the FDA product code for Flow-Nail?

The FDA product code for Flow-Nail is HSB.

Other Devices by Flow-Fx, LLC

K234075Flow-Nail

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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