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FDA 510(k)

UNiD Patient Specific 3D printed cage

K-Number: K173782 · 2018-04-25

ApplicantMedicrea International SA
Decision Date2018-04-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNiD Patient Specific 3D printed cage is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2018-04-25 under 510(k) number K173782. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNiD Patient Specific 3D printed cage?

UNiD Patient Specific 3D printed cage is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is Medicrea International SA. The 510(k) number is K173782.

When did UNiD Patient Specific 3D printed cage receive FDA 510(k) clearance?

UNiD Patient Specific 3D printed cage received FDA 510(k) clearance on 2018-04-25, under 510(k) number K173782.

Who is the listed applicant for UNiD Patient Specific 3D printed cage?

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

What is the FDA product code for UNiD Patient Specific 3D printed cage?

The FDA product code for UNiD Patient Specific 3D printed cage is MAX.

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Related Devices (Code: MAX)

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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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