PreXion 3D Excelsior
K-Number: K181983 · 2018-08-17
ApplicantPrexion Corporation
Decision Date2018-08-17
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion 3D Excelsior is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2018-08-17 under approval number K181983. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreXion 3D Excelsior?
PreXion 3D Excelsior is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Prexion Corporation. The 510(k) number is K181983.
When was PreXion 3D Excelsior approved by the FDA?
PreXion 3D Excelsior received FDA 510(k) clearance on 2018-08-17, under approval number K181983.
What company makes PreXion 3D Excelsior?
PreXion 3D Excelsior is manufactured by Prexion Corporation.
What is the FDA product code for PreXion 3D Excelsior?
The FDA product code for PreXion 3D Excelsior is OAS.
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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.