510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060346Substantially Equivalent

Ultrazonix Spine Minimal-Invasive Disc System

Ultrazonix Dnt AB, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060346 is the FDA 510(k) clearance record for ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM, a class II device, cleared for Ultrazonix Dnt AB on under FDA product code NTB (System, Ablation, Ultrasound And Accessories). FDA's definition for product code NTB reads: "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...". FDA records list one 510(k) clearance for Ultrazonix Dnt AB. As of , FDA records show no recalls naming K060346.

Clearance record

Decision date
Received
(315 days to decision)
Product code
NTB System, Ablation, Ultrasound And Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ultrazonix Dnt AB 7307 Glouchester Dr., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTB

Trailing 12 months

FDA records hold no clearances under product code NTB in the trailing twelve months.

FDA records show no clearances under product code NTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260