510(k) K240268

Accu-Joint Hemi Implant by Accufix Surgical, Inc. — Product Code KWD

K240268 is an FDA 510(k) premarket notification submitted by Accufix Surgical, Inc. for the device "Accu-Joint Hemi Implant". The FDA issued a decision of Substantially Equivalent on February 29, 2024. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Accufix Surgical, Inc. has at least 1 other 510(k) clearance on record.