510(k) K131393

MAK OSS FEMORAL KNEE COMPONENTS by Biomet Orthopedics Corp. — Product Code KRO

K131393 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics Corp. for the device "MAK OSS FEMORAL KNEE COMPONENTS". The FDA issued a decision of Substantially Equivalent on October 24, 2013. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Biomet Orthopedics Corp. has at least 10 other 510(k) clearances on record.