Home / 510(k) Clearances / K143276

510(k) K143276

Acumed Small Bone IM Nail System by Acumed, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2015
Date Received
November 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
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 HSB

  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)