510(k) K101730

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS by Zimmer, Inc. — Product Code KWZ

K101730 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS". The FDA issued a decision of Substantially Equivalent on December 3, 2010. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Zimmer, Inc. has at least 10 other 510(k) clearances on record.