# K023066: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)

- Pathway: 510(k) (Traditional)
- Applicant: Sodemsystems
- Decided: Nov 25, 2002 after 70 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Anspach Black Max: named in the summary without a submission number
- (no number) Anspach Micromax: named in the summary without a submission number

## Most influential descendants
- K042974: Medicon Vipair High Speed System (2005), 0 descendants of its own

## Indications for use
The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries. This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot...) applications.

Source page: https://510kreport.com/device/K023066
Methodology: https://510kreport.com/methodology