Home / 510(k) Clearances / K935567

510(k) K935567

SODEM POWER SYSTEM by Sodemsystems — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Sodemsystems

  • K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC) (January 28, 2003)
  • K023066 — DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (November 25, 2002)
  • K012457 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) (October 22, 2001)
  • K012453 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) (October 22, 2001)
  • K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) (September 21, 2001)
  • K993851 — SODEM PERFORATOR DRIVE (December 27, 1999)
  • K994175 — MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE (December 21, 1999)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)