ARVIS® Shoulder
K-Number: K243950 · 2025-01-13
Decision Date2025-01-13
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ARVIS® Shoulder is a medical device manufactured by Kico Knee Innovation Company Pty, Ltd.. It received FDA 510(k) clearance on 2025-01-13 under approval number K243950. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARVIS® Shoulder?
ARVIS® Shoulder is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Kico Knee Innovation Company Pty, Ltd.. The 510(k) number is K243950.
When was ARVIS® Shoulder approved by the FDA?
ARVIS® Shoulder received FDA 510(k) clearance on 2025-01-13, under approval number K243950.
What company makes ARVIS® Shoulder?
ARVIS® Shoulder is manufactured by Kico Knee Innovation Company Pty, Ltd..
What is the FDA product code for ARVIS® Shoulder?
The FDA product code for ARVIS® Shoulder is SBF.
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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.