Bolo Button System
K-Number: K242091 · 2024-12-23
ApplicantFusion Orthopedics
Decision Date2024-12-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Bolo Button System is a medical device manufactured by Fusion Orthopedics. It received FDA 510(k) clearance on 2024-12-23 under approval number K242091. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bolo Button System?
Bolo Button System is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Fusion Orthopedics. The 510(k) number is K242091.
When was Bolo Button System approved by the FDA?
Bolo Button System received FDA 510(k) clearance on 2024-12-23, under approval number K242091.
What company makes Bolo Button System?
Bolo Button System is manufactured by Fusion Orthopedics.
What is the FDA product code for Bolo Button System?
The FDA product code for Bolo Button System is HTN.
Related Clinical Trials
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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.