Home / 510(k) Clearances / K180541

510(k) K180541

DePuy Synthes 2.0 mm Quick Insertion Screws by Synthes USA Products, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2018
Date Received
March 1, 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 Synthes USA Products, LLC

  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K170654 — USS System (March 29, 2017)
  • K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated S (February 16, 2017)
  • K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (November 1, 2016)
  • K151276 — DePuy Synthes T-PAL Ti Spacer (June 18, 2015)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System (January 20, 2015)
  • K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (September 25, 2014)
  • K133698 — SYNAPSE SYSTEM (January 16, 2014)

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)