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FDA 510(k)

Axiom PSR System

K-Number: K223326 · 2023-03-30

ApplicantRestor3D
Decision Date2023-03-30
Product CodeOYK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axiom PSR System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2023-03-30 under approval number K223326. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiom PSR System?

Axiom PSR System is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Restor3D. The 510(k) number is K223326.

When was Axiom PSR System approved by the FDA?

Axiom PSR System received FDA 510(k) clearance on 2023-03-30, under approval number K223326.

What company makes Axiom PSR System?

Axiom PSR System is manufactured by Restor3D.

What is the FDA product code for Axiom PSR System?

The FDA product code for Axiom PSR System is OYK.

Related Clinical Trials

NCT07563803 The restor3d Outcomes Registry NOT_YET_RECRUITING

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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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