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FDA 510(k)

Ortho MI System

K-Number: K211992 · 2021-10-15

ApplicantOsteonic Co., Ltd.
Decision Date2021-10-15
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ortho MI System is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211992. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortho MI System?

Ortho MI System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K211992.

When did Ortho MI System receive FDA 510(k) clearance?

Ortho MI System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211992.

Who is the listed applicant for Ortho MI System?

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

What is the FDA product code for Ortho MI System?

The FDA product code for Ortho MI System is OAT.

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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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