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FDA 510(k)

SONIK MONARK 100

K-Number: K234036 · 2024-02-15

ApplicantNeuro Spinal Innovation, Inc.
Decision Date2024-02-15
Product CodeLXM
DecisionSubstantially Equivalent

Device Summary

SONIK MONARK 100 is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Spinal Innovation, Inc.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K234036. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIK MONARK 100?

SONIK MONARK 100 is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Neuro Spinal Innovation, Inc.. The 510(k) number is K234036.

When did SONIK MONARK 100 receive FDA 510(k) clearance?

SONIK MONARK 100 received FDA 510(k) clearance on 2024-02-15, under 510(k) number K234036.

Who is the listed applicant for SONIK MONARK 100?

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

What is the FDA product code for SONIK MONARK 100?

The FDA product code for SONIK MONARK 100 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.

K192629SpinalyticsOptima Health Solutions International Corp.K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc.K160278VSTAAR AdjusteRSpinal Acoustics, LLC

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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