Home / 510(k) Clearances / K971692

510(k) K971692

OSTEOPOWER SYSTEM AND ACCESSORIES by Osteomed Corp. — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1997
Date Received
May 7, 1997
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 Corp.

  • 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)
  • 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)

Other clearances for product code KMW

  • K211584 — Oral Surgery Contra (August 19, 2021)
  • K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece (November 21, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (July 29, 2008)
  • K994298 — FRIOS MICROSAW (February 18, 2000)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K932255 — YOUNG D'GRANULATOR (April 15, 1994)
  • K862110 — OSSEODENT DRILLING SYSTEM (August 7, 1986)