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FDA 510(k)

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM

K-Number: K060346 · 2006-12-22

ApplicantUltrazonix Dnt AB
Decision Date2006-12-22
Product CodeNTB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultrazonix Dnt AB. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K060346. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM?

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Ultrazonix Dnt AB. The 510(k) number is K060346.

When did ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM receive FDA 510(k) clearance?

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM received FDA 510(k) clearance on 2006-12-22, under 510(k) number K060346.

Who is the listed applicant for ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM?

The FDA 510(k) record lists Ultrazonix Dnt AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM?

The FDA product code for ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM is NTB.

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Related Devices (Code: NTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.K070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K042096MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1Epicor Medical, Inc.K022894EPICOR MEDICAL ABLATION SYSTEMEpicor Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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