Sodem High Speed System Electric

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Sodem High Speed System (Electric) (Neuro/Spine Surgery)

510(k) Number

K012457 ↗

FDA Product Code

HBC

Device Class

Class II

Regulation

21 CFR Part 882.4360

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Drill Guide Attachment PN 3105 DG

  Class II

  FDA 510(k) K023066 Active Cleared 25 Nov 2002

• Sodem Perforator Drive

  Class II

  FDA 510(k) K993851 Active Cleared 27 Dec 1999

• Sodem High Speed System (Pneumatic)

  Class II

  FDA 510(k) K023070 Active Cleared 28 Jan 2003

• Sodem Power System

  Class I

  FDA 510(k) K935567 Active Cleared 21 Jan 1994

• Sodem High Speed System (Electric) (Ear, Nose, and Throat)

  Class II

  FDA 510(k) K012456 Active Cleared 21 Sep 2001

• Modification to Sodem High Speed System for Neurosurgical Use

  Class II

  FDA 510(k) K994175 Active Cleared 21 Dec 1999

See all devices from Sodemsystems →

• What is the primary clinical application of the Sodem High Speed System?

  This powered surgical drill system is specifically designed for neuro and spine surgery. It is used for drilling, cutting, and sculpting cranial and spinal bones, and includes a dedicated motor for cranial perforation.

• What components are compatible with the Sodem High Speed System?

  The system features a motor that powers a variety of surgical attachments, including spindles, craniotomes, drills, burs, and cutters, as well as a specialized motor for skull perforation.

• What is the regulatory status of this device?

  The Sodem High Speed System is an electric motor drill classified under regulation number 882.4360. It has received FDA 510k clearance under the number K012457.