510(k) K253145

Pre-Sutured Tendon by Rti Surgical, Inc. — Product Code GAT

K253145 is an FDA 510(k) premarket notification submitted by Rti Surgical, Inc. for the device "Pre-Sutured Tendon". The FDA issued a decision of Substantially Equivalent on October 22, 2025. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Rti Surgical, Inc. has at least 6 other 510(k) clearances on record.