510(k) K212404

S.I.N. Instrument Kits by S.I.N. - Sistema DE Implante Nacional S.A. — Product Code KCT

K212404 is an FDA 510(k) premarket notification submitted by S.I.N. - Sistema DE Implante Nacional S.A. for the device "S.I.N. Instrument Kits". The FDA issued a decision of Substantially Equivalent on November 3, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. S.I.N. - Sistema DE Implante Nacional S.A. has at least 10 other 510(k) clearances on record.