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510(k) K234075

Flow-Nail by Flow-Fx, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2024
Date Received
January 10, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Flow-Fx, LLC

  • K221115 — Flow-Nail (May 13, 2022)
  • K142776 — Flow-Screw (March 23, 2015)
  • K140601 — FLOW-NAIL (July 2, 2014)

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