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510(k) K182212

Geo Staple System by Gramercy Extremity Orthopedics, LLC — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
August 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Gramercy Extremity Orthopedics, LLC

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  • K202817 — GEO Bone Screw System (October 22, 2020)
  • K200108 — GEO 1st MTP Joint Arthrodesis Plating System (March 26, 2020)

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  • K242415 — TMC Compression Implant System (September 6, 2024)
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  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
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