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FDA 510(k)

VSTAAR AdjusteR

K-Number: K160278 · 2016-11-04

ApplicantSpinal Acoustics, LLC
Decision Date2016-11-04
Product CodeLXM
DecisionSubstantially Equivalent

Device Summary

VSTAAR AdjusteR is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Acoustics, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160278. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSTAAR AdjusteR?

VSTAAR AdjusteR is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spinal Acoustics, LLC. The 510(k) number is K160278.

When did VSTAAR AdjusteR receive FDA 510(k) clearance?

VSTAAR AdjusteR received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160278.

Who is the listed applicant for VSTAAR AdjusteR?

The FDA 510(k) record lists Spinal Acoustics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSTAAR AdjusteR?

The FDA product code for VSTAAR AdjusteR is LXM.

Related Devices (Code: LXM)

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.

K234036SONIK MONARK 100Neuro Spinal Innovation, Inc.K192629SpinalyticsOptima Health Solutions International Corp.K172536Atlas Percussion Adjusting InstrumentSpinalight, 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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