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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2018-08-17 under 510(k) 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. The listed applicant is Prexion Corporation. The 510(k) number is K181983.

When did PreXion 3D Excelsior receive FDA 510(k) clearance?

PreXion 3D Excelsior received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181983.

Who is the listed applicant for PreXion 3D Excelsior?

The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreXion 3D Excelsior?

The FDA product code for PreXion 3D Excelsior is OAS.

Other records listing Prexion Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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