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510(k) K202680

OsteoMed ExtremiFix Mini & Small Cannulated Screw System by Osteomed, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
September 15, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Osteomed, LLC

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  • K173391 — OsteoMed QuickFix Hybrid MMF Sterilization Tray (May 10, 2018)
  • K162542 — OsteoMed PINNACLE Driver (May 19, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K163303 — OsteoMed ExtremiFix Mid and Large Screw System (April 4, 2017)
  • K161041 — OsteoMed ExtremiLOCK Wrist Plating System (May 19, 2016)
  • K152145 — OsteoMed ExtremiLOCK Wrist Plating System (December 21, 2015)
  • K151195 — OsteoMed IMF Screw (September 21, 2015)

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