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510(k) K173391

OsteoMed QuickFix Hybrid MMF Sterilization Tray by Osteomed, LLC — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2018
Date Received
October 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K152145 — OsteoMed ExtremiLOCK Wrist Plating System (December 21, 2015)
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