Home / 510(k) Clearances / K221115

510(k) K221115

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
April 15, 2022
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

  • K234075 — Flow-Nail (February 5, 2024)
  • K142776 — Flow-Screw (March 23, 2015)
  • K140601 — FLOW-NAIL (July 2, 2014)

Other clearances for product code HSB

  • K252016 — Arthrex Humeral Nails (March 20, 2026)
  • K252961 — Fusion FibFix Nail (March 18, 2026)
  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)