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510(k) K161041

OsteoMed ExtremiLOCK Wrist Plating System by Osteomed — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
April 13, 2016
Clearance Type
Special
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 Osteomed

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  • K202680 — OsteoMed ExtremiFix Mini & Small Cannulated Screw System (October 15, 2020)
  • 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)
  • K152145 — OsteoMed ExtremiLOCK Wrist Plating System (December 21, 2015)
  • K151195 — OsteoMed IMF Screw (September 21, 2015)

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