FDA 510(k)

Ortho System

K-Number: K180941 · 2018-10-17

Decision Date2018-10-17

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Ortho System is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2018-10-17 under 510(k) number K180941. 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 Ortho System?

Ortho System is a medical device that received FDA 510(k) clearance on 2018-10-17. The listed applicant is 3Shape A/S. The 510(k) number is K180941.

When did Ortho System receive FDA 510(k) clearance?

Ortho System received FDA 510(k) clearance on 2018-10-17, under 510(k) number K180941.

Who is the listed applicant for Ortho System?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ortho System?

The FDA product code for Ortho System is PNN.

Other records listing 3Shape A/S as applicant

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.

K200100Abutment Design K1919113Shape Splint Design K171634Ortho System K163677Ortho System K161884Ortho System K1514553Shape Abutment Designer Software

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Related Devices (Code: PNN)

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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.