ExcelsiusFlex
K-Number: K240721 · 2024-06-14
ApplicantGlobus Medical, Inc.
Decision Date2024-06-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ExcelsiusFlex is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-06-14 under approval number K240721. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ExcelsiusFlex?
ExcelsiusFlex is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Globus Medical, Inc.. The 510(k) number is K240721.
When was ExcelsiusFlex approved by the FDA?
ExcelsiusFlex received FDA 510(k) clearance on 2024-06-14, under approval number K240721.
What company makes ExcelsiusFlex?
ExcelsiusFlex is manufactured by Globus Medical, Inc..
What is the FDA product code for ExcelsiusFlex?
The FDA product code for ExcelsiusFlex is OLO.
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K151665SUSTAIN Additional Implants
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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.