HydroCision SpineJet System
K-Number: K200729 · 2020-04-16
ApplicantHydrocision, Inc.
Decision Date2020-04-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
HydroCision SpineJet System is a medical device manufactured by Hydrocision, Inc.. It received FDA 510(k) clearance on 2020-04-16 under approval number K200729. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HydroCision SpineJet System?
HydroCision SpineJet System is a medical device that received FDA 510(k) clearance on 2020-04-16. It is manufactured by Hydrocision, Inc.. The 510(k) number is K200729.
When was HydroCision SpineJet System approved by the FDA?
HydroCision SpineJet System received FDA 510(k) clearance on 2020-04-16, under approval number K200729.
What company makes HydroCision SpineJet System?
HydroCision SpineJet System is manufactured by Hydrocision, Inc..
What is the FDA product code for HydroCision SpineJet System?
The FDA product code for HydroCision SpineJet System is HRX.
Other Devices by Hydrocision, Inc.
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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.