DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)— 510(k) K023066

Name: FDA 510(k) clearance K023066
Creator: U.S. Food and Drug Administration
Published: 2002-11-25

Substantially Equivalent

Sodemsystems

FDA 510(k) clearance K023066 for DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC), Substantially Equivalent on 2002-11-25. Applicant: Sodemsystems. Device class: 2.

Clearance details

Applicant: Sodemsystems
Product code: Code HBB
Device class: Class 2
Regulation: 21 CFR 882.4370
Advisory panel: Neurology
Date received: 2002-09-16
Decision date: 2002-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

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More clearances from Sodemsystems

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K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC)2003-01-28
K012453 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)2001-10-22
K012457 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)2001-10-22
K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)2001-09-21
K993851 — SODEM PERFORATOR DRIVE1999-12-27

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.