510(k) K202193

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction by S.B.M. Sas (Science & Bio Materials) — Product Code MBI

K202193 is an FDA 510(k) premarket notification submitted by S.B.M. Sas (Science & Bio Materials) for the device "PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction". The FDA issued a decision of Substantially Equivalent on October 16, 2020. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. S.B.M. Sas (Science & Bio Materials) has at least 1 other 510(k) clearance on record.