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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 a medical device manufactured by Spinal Acoustics, LLC. It received FDA 510(k) clearance on 2016-11-04 under approval 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. It is manufactured by Spinal Acoustics, LLC. The 510(k) number is K160278.

When was VSTAAR AdjusteR approved by the FDA?

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

What company makes VSTAAR AdjusteR?

VSTAAR AdjusteR is manufactured by Spinal Acoustics, LLC.

What is the FDA product code for VSTAAR AdjusteR?

The FDA product code for VSTAAR AdjusteR is LXM.

Related Devices (Code: LXM)

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