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510(k) K023066

DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) by Sodemsystems — Product Code HBB

K023066 is an FDA 510(k) premarket notification submitted by Sodemsystems for the device "DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)". The FDA issued a decision of Substantially Equivalent on November 25, 2002. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Sodemsystems has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2002
Date Received
September 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

Other clearances by Sodemsystems

  • K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC) (January 28, 2003)
  • 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)
  • K935567 — SODEM POWER SYSTEM (January 21, 1994)

Other clearances for product code HBB

  • K253772 — Velocity Alpha MR High Speed Surgical Drill System (March 6, 2026)
  • K172907 — ELAN 4 Air Motor System (November 9, 2018)
  • K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo (March 23, 2017)
  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM (April 14, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)

FDA data resources