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FDA 510(k)

ON3D

K-Number: K221000 · 2022-05-23

Applicant3D Ons, Inc.
Decision Date2022-05-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ON3D is a medical device manufactured by 3D Ons, Inc.. It received FDA 510(k) clearance on 2022-05-23 under approval number K221000. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON3D?

ON3D is a medical device that received FDA 510(k) clearance on 2022-05-23. It is manufactured by 3D Ons, Inc.. The 510(k) number is K221000.

When was ON3D approved by the FDA?

ON3D received FDA 510(k) clearance on 2022-05-23, under approval number K221000.

What company makes ON3D?

ON3D is manufactured by 3D Ons, Inc..

What is the FDA product code for ON3D?

The FDA product code for ON3D is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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