Home / 510(k) Clearances / K182342

510(k) K182342

IntraLock Lapidus System by Fusion Orthopedics, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2019
Date Received
August 28, 2018
Clearance Type
Traditional
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 Fusion Orthopedics, LLC

  • K242091 — Bolo Button System (December 23, 2024)
  • K211843 — PolyLock Plating System (March 4, 2022)
  • K210159 — IntraLock System (July 23, 2021)
  • K193377 — TopLock Anchor System (November 25, 2020)
  • K202959 — PolyLock Plating System (November 24, 2020)
  • K192323 — PolyLock Small Bone Plating System (November 18, 2019)
  • K190136 — Fusion Silastic System (October 21, 2019)
  • K182684 — HammerTechTM Fixation System (November 23, 2018)
  • K181815 — DynaBridge (October 15, 2018)
  • K170624 — TalarLift STS (August 11, 2017)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • 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)