Clearance Summary
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM received FDA 510(k) clearance under submission number K060346, sponsored by Ultrazonix Dnt AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-12-22.
- Submission: K060346
- Applicant / Sponsor: Ultrazonix Dnt AB
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2006-12-22
Classification & Regulation
This clearance is catalogued under FDA product code NTB and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.