510(k) K222964

BioPoly Lesser Toe Hemiarthroplasty Implant by BioPoly, LLC — Product Code KWD

K222964 is an FDA 510(k) premarket notification submitted by BioPoly, LLC for the device "BioPoly Lesser Toe Hemiarthroplasty Implant". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. BioPoly, LLC has at least 2 other 510(k) clearances on record.