510(k) K263461

Tendon Anchor by Smith & Nephew, Inc. — Product Code GDW

K263461 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Tendon Anchor". The FDA issued a decision of Substantially Equivalent on Oct 27, 2026. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Smith & Nephew, Inc. has 556 other 510(k) clearances on record.