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 a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-10-15 under approval 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. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K211992.
When was Ortho MI System approved by the FDA?
Ortho MI System received FDA 510(k) clearance on 2021-10-15, under approval number K211992.
What company makes Ortho MI System?
Ortho MI System is manufactured by Osteonic Co., Ltd..
What is the FDA product code for Ortho MI System?
The FDA product code for Ortho MI System is OAT.
Other Devices by Osteonic Co., Ltd.
Related Devices (Code: OAT)
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.