FDA 510(k)

3D-Cut

K-Number: K212237 · 2021-11-29

Decision Date2021-11-29

Product CodePBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

3D-Cut is a medical device manufactured by 3D-Side S.A.. It received FDA 510(k) clearance on 2021-11-29 under approval number K212237. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-Cut?

3D-Cut is a medical device that received FDA 510(k) clearance on 2021-11-29. It is manufactured by 3D-Side S.A.. The 510(k) number is K212237.

When was 3D-Cut approved by the FDA?

3D-Cut received FDA 510(k) clearance on 2021-11-29, under approval number K212237.

What company makes 3D-Cut?

3D-Cut is manufactured by 3D-Side S.A..

What is the FDA product code for 3D-Cut?

The FDA product code for 3D-Cut is PBF.

Other Devices by 3D-Side S.A.

K221432Customize K213779Customize

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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.