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FDA 510(k)

Ortho System

K-Number: K161884 · 2017-04-19

Applicant3Shape A/S
Decision Date2017-04-19
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Ortho System is a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2017-04-19 under approval number K161884. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortho System?

Ortho System is a medical device that received FDA 510(k) clearance on 2017-04-19. It is manufactured by 3Shape A/S. The 510(k) number is K161884.

When was Ortho System approved by the FDA?

Ortho System received FDA 510(k) clearance on 2017-04-19, under approval number K161884.

What company makes Ortho System?

Ortho System is manufactured by 3Shape A/S.

What is the FDA product code for Ortho System?

The FDA product code for Ortho System is MQC.

Other Devices by 3Shape A/S

K1514553Shape Abutment Designer Software K1520863Shape Ortho System K163677Ortho System K180941Ortho System K171634Ortho System K1919113Shape Splint Design

View all 8 devices →

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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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