SCARLET AC-T
K-Number: K172065 · 2017-09-29
ApplicantSpineart
Decision Date2017-09-29
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SCARLET AC-T is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2017-09-29 under approval number K172065. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SCARLET AC-T?
SCARLET AC-T is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Spineart. The 510(k) number is K172065.
When was SCARLET AC-T approved by the FDA?
SCARLET AC-T received FDA 510(k) clearance on 2017-09-29, under approval number K172065.
What company makes SCARLET AC-T?
SCARLET AC-T is manufactured by Spineart.
What is the FDA product code for SCARLET AC-T?
The FDA product code for SCARLET AC-T is ODP.
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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.