Scarlet® AL-T
K-Number: K242589 · 2024-10-23
ApplicantSpineart SA
Decision Date2024-10-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Scarlet® AL-T is a medical device manufactured by Spineart SA. It received FDA 510(k) clearance on 2024-10-23 under approval number K242589. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Scarlet® AL-T?
Scarlet® AL-T is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Spineart SA. The 510(k) number is K242589.
When was Scarlet® AL-T approved by the FDA?
Scarlet® AL-T received FDA 510(k) clearance on 2024-10-23, under approval number K242589.
What company makes Scarlet® AL-T?
Scarlet® AL-T is manufactured by Spineart SA.
What is the FDA product code for Scarlet® AL-T?
The FDA product code for Scarlet® AL-T is MAX.
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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.