510(k) K101475

COMPRESS ANTI-ROTATION SPINDLES by Biomet Manufacturing Corp — Product Code KWA

K101475 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "COMPRESS ANTI-ROTATION SPINDLES". The FDA issued a decision of Substantially Equivalent on June 18, 2010. 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 Corp has at least 10 other 510(k) clearances on record.