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 the device name listed in this FDA 510(k) record. The listed applicant is Inteware Co., Ltd.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) 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. The listed applicant is Inteware Co., Ltd.. The 510(k) number is K173965.

When did Implant Planning Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Implant Planning Software?

The FDA 510(k) record lists Inteware Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant Planning Software?

The FDA product code for Implant Planning Software is LLZ.

Other records listing Inteware Co., Ltd. as applicant

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.