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FDA 510(k)

Orchestrate 3D

K-Number: K181112 · 2018-11-26

ApplicantOrchestrate 3D
Decision Date2018-11-26
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orchestrate 3D is a medical device manufactured by Orchestrate 3D. It received FDA 510(k) clearance on 2018-11-26 under approval number K181112. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orchestrate 3D?

Orchestrate 3D is a medical device that received FDA 510(k) clearance on 2018-11-26. It is manufactured by Orchestrate 3D. The 510(k) number is K181112.

When was Orchestrate 3D approved by the FDA?

Orchestrate 3D received FDA 510(k) clearance on 2018-11-26, under approval number K181112.

What company makes Orchestrate 3D?

Orchestrate 3D is manufactured by Orchestrate 3D.

What is the FDA product code for Orchestrate 3D?

The FDA product code for Orchestrate 3D is PNN.

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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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