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510(k) K240530

DynaNail Mini Tapered Hybrid by MedShape, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
February 23, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by MedShape, Inc.

  • K250628 — DynaNail TTC Fusion System (September 12, 2025)
  • K220812 — DynaClip® Bone Staple (August 19, 2022)
  • K203595 — DynaFuse Fixation System (January 4, 2022)
  • K203381 — Dynanail Mini Hybrid (January 15, 2021)
  • K193305 — DynaClip Bone Staple (April 23, 2020)
  • K182677 — DynaNail Mini (February 14, 2019)
  • K181781 — DynaClipTM Bone Staple (November 5, 2018)
  • K171376 — DynaNail TTC Fusion System (November 2, 2017)
  • K141420 — FASTFORWARD (December 18, 2014)
  • K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREW (September 29, 2014)

Other clearances for product code HWC

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  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)