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FDA 510(k)

IB3D ALIF

K-Number: K191134 · 2019-10-30

ApplicantMedicrea International SA
Decision Date2019-10-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IB3D ALIF 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 2019-10-30 under 510(k) number K191134. 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 IB3D ALIF?

IB3D ALIF is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Medicrea International SA. The 510(k) number is K191134.

When did IB3D ALIF receive FDA 510(k) clearance?

IB3D ALIF received FDA 510(k) clearance on 2019-10-30, under 510(k) number K191134.

Who is the listed applicant for IB3D ALIF?

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 IB3D ALIF?

The FDA product code for IB3D ALIF is 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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