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510(k) K162544

OsteoMed PINNACLE Driver by Osteomed — Product Code KMW

K162544 is an FDA 510(k) premarket notification submitted by Osteomed for the device "OsteoMed PINNACLE Driver". The FDA issued a decision of Substantially Equivalent on April 4, 2017. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Osteomed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Osteomed

  • K212570 — OsteoPlan System (February 11, 2022)
  • 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)
  • 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)

Other clearances for product code KMW

  • K211584 — Oral Surgery Contra (August 19, 2021)
  • K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece (November 21, 2017)
  • K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (July 29, 2008)
  • K994298 — FRIOS MICROSAW (February 18, 2000)
  • K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES (June 27, 1997)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K932255 — YOUNG D'GRANULATOR (April 15, 1994)
  • K862110 — OSSEODENT DRILLING SYSTEM (August 7, 1986)

FDA data resources