Home / 510(k) Clearances / K170594

510(k) K170594

I.B.S. osteosynthesis screws by In2bones Sas — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2017
Date Received
February 28, 2017
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 In2bones Sas

  • K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System (April 23, 2024)
  • K230313 — QUANTUM Patient Specific Instrumentation (PSI) System (April 6, 2023)
  • K211883 — QUANTUM® Patient Specific Instrumentation (PSI) System (August 11, 2021)
  • K191380 — Quantum® Total Ankle Prosthesis (January 29, 2020)
  • K173811 — TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System (March 15, 2018)
  • K173616 — DIP Arthrodesis System (January 19, 2018)
  • K173121 — Ankle Fusion Plating System (November 28, 2017)
  • K170688 — PIT’Stop® implant (November 28, 2017)
  • K160174 — I.B.S. 2.0 Osteosynthesis screw (October 6, 2016)
  • K160995 — NEOVIEW Plating System (June 10, 2016)

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)