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510(k) K152145

OsteoMed ExtremiLOCK Wrist Plating System by Osteomed — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2015
Date Received
August 3, 2015
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 Osteomed

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  • K203479 — ExtremiLOCK Lateral Ankle Fusion Plates (February 24, 2021)
  • K202105 — OsteoMed ExtremiFix Mini & Small System Tray (October 29, 2020)
  • 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)
  • K161041 — OsteoMed ExtremiLOCK Wrist Plating System (May 19, 2016)
  • K151195 — OsteoMed IMF Screw (September 21, 2015)

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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