Home / 510(k) Clearances / K250628

510(k) K250628

DynaNail TTC Fusion System by MedShape, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
March 3, 2025
Clearance Type
Traditional
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 MedShape, Inc.

  • K240530 — DynaNail Mini Tapered Hybrid (March 21, 2024)
  • 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 HSB

  • 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)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)