Home / 510(k) Clearances / K933101

510(k) K933101

THE OSTEOMED B POWER SYSTEM AND ACCESSORIES by Osteomed Corp. — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1994
Date Received
June 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
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 KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (September 4, 1997)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933337 — R AND D BATTERY REPLACEMENT (April 5, 1994)