Balanced Knee System Uni
K-Number: K211471 · 2021-12-16
ApplicantOrtho Development Corporation
Decision Date2021-12-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Balanced Knee System Uni is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2021-12-16 under approval number K211471. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Balanced Knee System Uni?
Balanced Knee System Uni is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Ortho Development Corporation. The 510(k) number is K211471.
When was Balanced Knee System Uni approved by the FDA?
Balanced Knee System Uni received FDA 510(k) clearance on 2021-12-16, under approval number K211471.
What company makes Balanced Knee System Uni?
Balanced Knee System Uni is manufactured by Ortho Development Corporation.
What is the FDA product code for Balanced Knee System Uni?
The FDA product code for Balanced Knee System Uni is HSX.
Other Devices by Ortho Development Corporation
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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.