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 a medical device manufactured by Neuro Spinal Innovation, Inc.. It received FDA 510(k) clearance on 2024-02-15 under approval 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. It is manufactured by Neuro Spinal Innovation, Inc.. The 510(k) number is K234036.
When was SONIK MONARK 100 approved by the FDA?
SONIK MONARK 100 received FDA 510(k) clearance on 2024-02-15, under approval number K234036.
What company makes SONIK MONARK 100?
SONIK MONARK 100 is manufactured by Neuro Spinal Innovation, Inc..
What is the FDA product code for SONIK MONARK 100?
The FDA product code for SONIK MONARK 100 is LXM.
Related Devices (Code: LXM)
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.