SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)— 510(k) K012453

Clearance details

Applicant

Sodemsystems

Product code

Code HBC

Device class

Class 2

Regulation

21 CFR 882.4360

Advisory panel

Neurology

Date received

2001-08-01

Decision date

2001-10-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Geneva, CH

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• K232938 — Traus SSG30 Surgical System2024-09-16
• K213697 — ORiGO System2022-10-31
• K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)2022-05-19

• K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC)2003-01-28
• K023066 — DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)2002-11-25
• 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

Malfunction

4,715

Total

4,715

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 →