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FDA 510(k)

Portux CAD/CAM Disc

K-Number: K192153 · 2019-11-07

ApplicantNew Stetic, SA
Decision Date2019-11-07
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portux CAD/CAM Disc is the device name listed in this FDA 510(k) record. The listed applicant is New Stetic, SA. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192153. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portux CAD/CAM Disc?

Portux CAD/CAM Disc is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is New Stetic, SA. The 510(k) number is K192153.

When did Portux CAD/CAM Disc receive FDA 510(k) clearance?

Portux CAD/CAM Disc received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192153.

Who is the listed applicant for Portux CAD/CAM Disc?

The FDA 510(k) record lists New Stetic, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portux CAD/CAM Disc?

The FDA product code for Portux CAD/CAM Disc is EBG.

Other records listing New Stetic, SA 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.

K254245ZAFIRA®

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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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