Drill Guide Attachment PN 3105 DG

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

Full name

Drill Guide Attachment (Pn 3105 Dg) of the Sodem High Speed System (Pneumatic)

510(k) Number

K023066 ↗

FDA Product Code

HBB

Device Class

Class II

Regulation

21 CFR Part 882.4370

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• 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

• Sodem High Speed System Electric

  Class II

  FDA 510(k) K012457 Active Cleared 22 Oct 2001

See all devices from Sodemsystems →

• What is the primary function of the Drill Guide Attachment PN 3105 DG?

  This attachment is designed to facilitate the creation of holes at adjustable depths. It serves as a component of the Sodem High Speed System, allowing for the operation of drills and cutters during various surgical procedures.

• Which surgical specialties is this drill guide indicated for?

  The device is indicated for use in neurology, including spine and craniotomy procedures. It is also suitable for general plastic surgery, such as median sternotomy, and orthopedic applications, including extremity procedures and revision implant surgery.

• What is the regulatory status of this device?

  The Drill Guide Attachment PN 3105 DG has received FDA 510(k) clearance under K023066. This indicates that the device was found to be substantially equivalent to other legally marketed devices within the neurology medical specialty.