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510(k) K200108

GEO 1st MTP Joint Arthrodesis Plating System by Gramercy Extremity Orthopedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
January 17, 2020
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 Gramercy Extremity Orthopedics, LLC

  • K212334 — GEO Extremity and Ankle Plating System (September 21, 2021)
  • K210534 — GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (March 26, 2021)
  • K202817 — GEO Bone Screw System (October 22, 2020)
  • K182212 — Geo Staple System (January 11, 2019)

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