510(k) K990712

OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM by Howmedica Osteonics Corp. — Product Code MJT

K990712 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 1999. The device falls under product code MJT (Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented), a Class III device. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.