Optimus NEURO System - Sterile Kit
K-Number: K190811 · 2019-11-27
ApplicantOsteonic Co., Ltd.
Decision Date2019-11-27
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optimus NEURO System - Sterile Kit is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2019-11-27 under approval number K190811. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optimus NEURO System - Sterile Kit?
Optimus NEURO System - Sterile Kit is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K190811.
When was Optimus NEURO System - Sterile Kit approved by the FDA?
Optimus NEURO System - Sterile Kit received FDA 510(k) clearance on 2019-11-27, under approval number K190811.
What company makes Optimus NEURO System - Sterile Kit?
Optimus NEURO System - Sterile Kit is manufactured by Osteonic Co., Ltd..
What is the FDA product code for Optimus NEURO System - Sterile Kit?
The FDA product code for Optimus NEURO System - Sterile Kit is GWO.
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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.