ON3D
K-Number: K221000 · 2022-05-23
Applicant3D Ons, Inc.
Decision Date2022-05-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ON3D is the device name listed in this FDA 510(k) record. The listed applicant is 3D Ons, Inc.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) 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. The listed applicant is 3D Ons, Inc.. The 510(k) number is K221000.
When did ON3D receive FDA 510(k) clearance?
ON3D received FDA 510(k) clearance on 2022-05-23, under 510(k) number K221000.
Who is the listed applicant for ON3D?
The FDA 510(k) record lists 3D Ons, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ON3D?
The FDA product code for ON3D is LLZ.
Related Devices (Code: LLZ)
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.
Official Source
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