SCARLET® AC-Ti
K-Number: K240699 · 2024-05-10
ApplicantSpineart SA
Decision Date2024-05-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SCARLET® AC-Ti is a medical device manufactured by Spineart SA. It received FDA 510(k) clearance on 2024-05-10 under approval number K240699. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SCARLET® AC-Ti?
SCARLET® AC-Ti is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Spineart SA. The 510(k) number is K240699.
When was SCARLET® AC-Ti approved by the FDA?
SCARLET® AC-Ti received FDA 510(k) clearance on 2024-05-10, under approval number K240699.
What company makes SCARLET® AC-Ti?
SCARLET® AC-Ti is manufactured by Spineart SA.
What is the FDA product code for SCARLET® AC-Ti?
The FDA product code for SCARLET® AC-Ti is OVE.
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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.