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FDA 510(k)

OssGuide

K-Number: K200623 · 2020-10-02

ApplicantSk Bioland Co., Ltd.
Decision Date2020-10-02
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OssGuide is a medical device manufactured by Sk Bioland Co., Ltd.. It received FDA 510(k) clearance on 2020-10-02 under approval number K200623. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OssGuide?

OssGuide is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Sk Bioland Co., Ltd.. The 510(k) number is K200623.

When was OssGuide approved by the FDA?

OssGuide received FDA 510(k) clearance on 2020-10-02, under approval number K200623.

What company makes OssGuide?

OssGuide is manufactured by Sk Bioland Co., Ltd..

What is the FDA product code for OssGuide?

The FDA product code for OssGuide is NPL.

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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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