510(k) K113271

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS by Biomet Manufacturing, Inc. — Product Code KWA

K113271 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, Inc. for the device "METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS". The FDA issued a decision of Substantially Equivalent on May 18, 2012. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Biomet Manufacturing, Inc. has at least 10 other 510(k) clearances on record.