The following data is part of a premarket notification filed by Ultrazonix Dnt Ab with the FDA for Ultrazonix Spine Minimal-invasive Disc System.
| Device ID | K060346 |
| 510k Number | K060346 |
| Device Name: | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM |
| Classification | System, Ablation, Ultrasound And Accessories |
| Applicant | ULTRAZONIX DNT AB 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman ULTRAZONIX DNT AB 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | NTB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-12-22 |
| Summary: | summary |