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FDA 510(k)

IMPIX 3D Print Cages

K-Number: K163595 · 2017-11-13

ApplicantMedicrea International SA
Decision Date2017-11-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPIX 3D Print Cages 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 2017-11-13 under 510(k) number K163595. 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 IMPIX 3D Print Cages?

IMPIX 3D Print Cages is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Medicrea International SA. The 510(k) number is K163595.

When did IMPIX 3D Print Cages receive FDA 510(k) clearance?

IMPIX 3D Print Cages received FDA 510(k) clearance on 2017-11-13, under 510(k) number K163595.

Who is the listed applicant for IMPIX 3D Print Cages?

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 IMPIX 3D Print Cages?

The FDA product code for IMPIX 3D Print Cages 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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