FlexitSystem Knee osteotomy system
K-Number: K212545 · 2022-02-11
ApplicantNeosteo
Decision Date2022-02-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FlexitSystem Knee osteotomy system is a medical device manufactured by Neosteo. It received FDA 510(k) clearance on 2022-02-11 under approval number K212545. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FlexitSystem Knee osteotomy system?
FlexitSystem Knee osteotomy system is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Neosteo. The 510(k) number is K212545.
When was FlexitSystem Knee osteotomy system approved by the FDA?
FlexitSystem Knee osteotomy system received FDA 510(k) clearance on 2022-02-11, under approval number K212545.
What company makes FlexitSystem Knee osteotomy system?
FlexitSystem Knee osteotomy system is manufactured by Neosteo.
What is the FDA product code for FlexitSystem Knee osteotomy system?
The FDA product code for FlexitSystem Knee osteotomy system is HRS.
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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.