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510(k) K190658

MIS Bunion Plating System by Crossroads Extremity Systems, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
March 14, 2019
Clearance Type
Special
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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  • K223342 — MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, Dyna (March 30, 2023)
  • K220797 — FootHold System (April 15, 2022)
  • K202268 — CrossRoads Tray System (December 30, 2020)
  • 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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  • 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)
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