PreXion3D Excelsior
K-Number: K161881 · 2016-10-03
ApplicantPrexion Corporation
Decision Date2016-10-03
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion3D Excelsior is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2016-10-03 under approval number K161881. 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 PreXion3D Excelsior?
PreXion3D Excelsior is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Prexion Corporation. The 510(k) number is K161881.
When was PreXion3D Excelsior approved by the FDA?
PreXion3D Excelsior received FDA 510(k) clearance on 2016-10-03, under approval number K161881.
What company makes PreXion3D Excelsior?
PreXion3D Excelsior is manufactured by Prexion Corporation.
What is the FDA product code for PreXion3D Excelsior?
The FDA product code for PreXion3D Excelsior is OAS.
Other Devices by Prexion Corporation
Related Devices (Code: OAS)
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.