# Sodemsystems

- Location (FDA's records): Geneva, CH
- FDA decisions: 8 (1994–2003): 8 510(k) clearances
- Product codes: HBB (3), ERL (2), HBC (2), HWE (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 13 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Linvatec Corp.: 6 (https://510kreport.com/company/linvatec)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- The Anspach Effort, Inc.: 2 (https://510kreport.com/company/anspach-effort)
- Sodem Diffusion SA: 1 (https://510kreport.com/company/sodem-diffusion)

## Firms that cite its devices most
- Medtronic Xomed, Inc.: 8 (https://510kreport.com/company/medtronic-xomed)
- Bioplate, Inc.: 2 (https://510kreport.com/company/bioplate)
- Medicon EG: 1 (https://510kreport.com/company/medicon-eg)
- Medtronic Powered Surgical Solutions: 1 (https://510kreport.com/company/medtronic-powered-surgical-solutions)

## Its most-cited devices
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (2001), cited by 4
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (2001), cited by 3
- K935567: Sodem Power System (1994), cited by 3
- K012456: Sodem High Speed System (Electric) (Ear, Nose, and Throat) (2001), cited by 2
- K023066: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic) (2002), cited by 1

## Recent decisions
- K023070: Sodem High Speed System (Pneumatic) (Jan 28, 2003)
- K023066: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic) (Nov 25, 2002)
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (Oct 22, 2001)
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (Oct 22, 2001)
- K012456: Sodem High Speed System (Electric) (Ear, Nose, and Throat) (Sep 21, 2001)
- K993851: Sodem Perforator Drive (Dec 27, 1999)
- K994175: Modification to Sodem High Speed System for Neurosurgical Use (Dec 21, 1999)
- K935567: Sodem Power System (Jan 21, 1994)

Source page: https://510kreport.com/company/sodemsystems