Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spinalytics

K-Number: K192629 · 2019-12-21

ApplicantOptima Health Solutions International Corp.
Decision Date2019-12-21
Product CodeLXM
DecisionSubstantially Equivalent

Device Summary

Spinalytics is a medical device manufactured by Optima Health Solutions International Corp.. It received FDA 510(k) clearance on 2019-12-21 under approval number K192629. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spinalytics?

Spinalytics is a medical device that received FDA 510(k) clearance on 2019-12-21. It is manufactured by Optima Health Solutions International Corp.. The 510(k) number is K192629.

When was Spinalytics approved by the FDA?

Spinalytics received FDA 510(k) clearance on 2019-12-21, under approval number K192629.

What company makes Spinalytics?

Spinalytics is manufactured by Optima Health Solutions International Corp..

What is the FDA product code for Spinalytics?

The FDA product code for Spinalytics is LXM.

Related Devices (Code: LXM)

K160278VSTAAR AdjusteRSpinal Acoustics, LLC K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc. 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.

↑