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510(k) K181872

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2019
Date Received
July 12, 2018
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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  • 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)
  • K190658 — MIS Bunion Plating System (April 12, 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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