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510(k) K935567

SODEM POWER SYSTEM by Sodemsystems — Product Code HWE

K935567 is an FDA 510(k) premarket notification submitted by Sodemsystems for the device "SODEM POWER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Sodemsystems has at least 7 other 510(k) clearances on record.

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)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources