The following data is part of a premarket notification filed by Sodem Systems with the FDA for Sodem High Speed System (electric) (neuro/spine Surgery).
| Device ID | K012457 |
| 510k Number | K012457 |
| Device Name: | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) |
| Classification | Motor, Drill, Electric |
| Applicant | SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Contact | Carole Burnier |
| Correspondent | Carole Burnier SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2001-10-22 |
| Summary: | summary |