Home / 510(k) Clearances / K252901

510(k) K252901

Tyber Medical Trauma Screw by Tyber Medical, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2025
Date Received
September 11, 2025
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 Tyber Medical, LLC

  • K252742 — Navigated Instruments (October 28, 2025)
  • K251361 — Tyber Medical Distal Radius Plating System (July 30, 2025)
  • K242486 — Tyber Medical Anatomical Plating System (March 19, 2025)
  • K241218 — Tyber Medical Anatomical Plating System (May 31, 2024)
  • K233423 — Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (December 21, 2023)
  • K233017 — TM Plating System (December 20, 2023)
  • K232652 — Anatomical Plating System (various) (December 13, 2023)
  • K232693 — Tyber Medical Distal Radius Plating System (December 4, 2023)
  • K231339 — Tyber Medical Pin and Wire System (various) (July 6, 2023)
  • K222465 — Tyber Medical Anatomical Plating System (March 7, 2023)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • 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)
  • K243943 — TriMed® Compression Screws (April 10, 2025)