Balex bone Expander System
K-Number: K202027 · 2021-02-03
ApplicantTaeyeon Medical Co., Ltd.
Decision Date2021-02-03
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Balex bone Expander System is a medical device manufactured by Taeyeon Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-02-03 under approval number K202027. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Balex bone Expander System?
Balex bone Expander System is a medical device that received FDA 510(k) clearance on 2021-02-03. It is manufactured by Taeyeon Medical Co., Ltd.. The 510(k) number is K202027.
When was Balex bone Expander System approved by the FDA?
Balex bone Expander System received FDA 510(k) clearance on 2021-02-03, under approval number K202027.
What company makes Balex bone Expander System?
Balex bone Expander System is manufactured by Taeyeon Medical Co., Ltd..
What is the FDA product code for Balex bone Expander System?
The FDA product code for Balex bone Expander System is HRX.
Related Clinical Trials
Other Devices by Taeyeon Medical Co., Ltd.
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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.