Home / 510(k) Clearances / K251361

510(k) K251361

Tyber Medical Distal Radius Plating System by Tyber Medical, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2025
Date Received
May 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Tyber Medical, LLC

  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K252742 — Navigated Instruments (October 28, 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 HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)