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FDA 510(k)

Implant Planning Software

K-Number: K173965 · 2018-10-26

Decision Date2018-10-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Implant Planning Software is a medical device manufactured by Inteware Co., Ltd.. It received FDA 510(k) clearance on 2018-10-26 under approval number K173965. 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 Planning Software?

Implant Planning Software is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Inteware Co., Ltd.. The 510(k) number is K173965.

When was Implant Planning Software approved by the FDA?

Implant Planning Software received FDA 510(k) clearance on 2018-10-26, under approval number K173965.

What company makes Implant Planning Software?

Implant Planning Software is manufactured by Inteware Co., Ltd..

What is the FDA product code for Implant Planning Software?

The FDA product code for Implant Planning Software is LLZ.

Related Clinical Trials

Related PubMed Literature

Other Devices by Inteware Co., Ltd.

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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.