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FDA 510(k)

IMPLANT 3D

K-Number: K153091 · 2016-02-25

ApplicantMedia Lab S.R.L.
Decision Date2016-02-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPLANT 3D is a medical device manufactured by Media Lab S.R.L.. It received FDA 510(k) clearance on 2016-02-25 under approval number K153091. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT 3D?

IMPLANT 3D is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Media Lab S.R.L.. The 510(k) number is K153091.

When was IMPLANT 3D approved by the FDA?

IMPLANT 3D received FDA 510(k) clearance on 2016-02-25, under approval number K153091.

What company makes IMPLANT 3D?

IMPLANT 3D is manufactured by Media Lab S.R.L..

What is the FDA product code for IMPLANT 3D?

The FDA product code for IMPLANT 3D is LLZ.

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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.

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