510(k) K925420

TECHMEDICA STANDARD BIPOLAR SYSTEM by Techmedica, Inc. — Product Code KWY

K925420 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TECHMEDICA STANDARD BIPOLAR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 1993. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Techmedica, Inc. has at least 10 other 510(k) clearances on record.