510(k) K211883

QUANTUM® Patient Specific Instrumentation (PSI) System by In2bones Sas — Product Code HSN

K211883 is an FDA 510(k) premarket notification submitted by In2bones Sas for the device "QUANTUM® Patient Specific Instrumentation (PSI) System". The FDA issued a decision of Substantially Equivalent on August 11, 2021. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. In2bones Sas has at least 10 other 510(k) clearances on record.