510(k) K203855

CoNextions TR Tendon Repair System by Conextions Medical — Product Code GAQ

K203855 is an FDA 510(k) premarket notification submitted by Conextions Medical for the device "CoNextions TR Tendon Repair System". The FDA issued a decision of Substantially Equivalent on April 22, 2022. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Conextions Medical has at least 1 other 510(k) clearance on record.