510(k) K231033

CEPTRE® Knotted UHMWPE Suture PEEK Anchor by Healthium Medtech Limited — Product Code MBI

K231033 is an FDA 510(k) premarket notification submitted by Healthium Medtech Limited for the device "CEPTRE® Knotted UHMWPE Suture PEEK Anchor". The FDA issued a decision of Substantially Equivalent on January 4, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Healthium Medtech Limited has at least 4 other 510(k) clearances on record.