The following data is part of a premarket notification filed by Sodem Systems with the FDA for Sodem High Speed System (electric) (general Orthopedics & Plastic Surgery).
| Device ID | K012453 |
| 510k Number | K012453 |
| Device Name: | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994612168 | K012453 | 000 |
| 10885074609536 | K012453 | 000 |
| 10885074609550 | K012453 | 000 |
| 10885074609567 | K012453 | 000 |
| 10885074609574 | K012453 | 000 |
| 00763000430887 | K012453 | 000 |
| 00763000430894 | K012453 | 000 |
| 10885074636402 | K012453 | 000 |
| 00721902573583 | K012453 | 000 |
| 00643169999152 | K012453 | 000 |
| 00643169999176 | K012453 | 000 |
| 10885074609482 | K012453 | 000 |