FDA 510(k)

IMPLANT 3D

K-Number: K153091 · 2016-02-25

Decision Date2016-02-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMPLANT 3D is the device name listed in this FDA 510(k) record. The listed applicant is Media Lab S.R.L.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) 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. The listed applicant is Media Lab S.R.L.. The 510(k) number is K153091.

When did IMPLANT 3D receive FDA 510(k) clearance?

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

Who is the listed applicant for IMPLANT 3D?

The FDA 510(k) record lists Media Lab S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT 3D?

The FDA product code for IMPLANT 3D is LLZ.

Related Devices (Code: LLZ)

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.

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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.