Home / 510(k) Clearances / K131764

510(k) K131764

ACUMED WRIST SPANNING PLATE by Acumed, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2013
Date Received
June 17, 2013
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 Acumed, LLC

  • K252356 — The Acumed Wrist Fixation System - 2.4mm Screws (August 21, 2025)
  • K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Sc (July 14, 2025)
  • K251296 — The Acumed Wrist Fixation System (June 18, 2025)
  • K243624 — Acu-Sinch Knotless Mini (January 23, 2025)
  • K233311 — Acumed Wrist Plating System (April 22, 2024)
  • K230744 — Acumed Acutrak 3 Headless Compression Screw System (June 9, 2023)
  • K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (December 29, 2022)
  • K212990 — Acumed Ankle Syndesmosis Repair System (January 7, 2022)
  • K210750 — Acumed Clavicle Hook Plating System (July 15, 2021)
  • K151886 — Acumed Ankle and Small Fragment Base Set Update (October 30, 2015)

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)