510(k) K820813

LESSER METATARSAL PHALANG. JOINT PROSTH by Sutter Biomedical, Inc. — Product Code KWH

K820813 is an FDA 510(k) premarket notification submitted by Sutter Biomedical, Inc. for the device "LESSER METATARSAL PHALANG. JOINT PROSTH". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Sutter Biomedical, Inc. has at least 10 other 510(k) clearances on record.