K060346 is an FDA 510(k) clearance for the ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM. This device is classified as a System, Ablation, Ultrasound And Accessories (Class II - Special Controls, product code NTB).
Submitted by Ultrazonix Dnt AB (Minneapolis, US). The FDA issued a Cleared decision on December 22, 2006, 315 days after receiving the submission on February 10, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery..
| 510(k) Number | K060346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NTB — System, Ablation, Ultrasound And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery. |