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510(k) K223342

MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System by Crossroads Extremity Systems, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2023
Date Received
November 1, 2022
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 Crossroads Extremity Systems, LLC

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  • K230591 — TriLEAP Plating System (September 29, 2023)
  • K220797 — FootHold System (April 15, 2022)
  • K202268 — CrossRoads Tray System (December 30, 2020)
  • K190658 — MIS Bunion Plating System (April 12, 2019)
  • K181872 — MIS Bunion System (February 19, 2019)
  • K181866 — MotoCLIP/HiMAX Step Staple Implant System (August 9, 2018)
  • K181410 — MotoCLIP/HiMAX Implant System (June 29, 2018)
  • K173710 — MotoBAND CP Implant System (February 12, 2018)

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  • 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)