IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY

IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY is an FDA 510(k)-cleared medical device (K983128) manufactured by Implex Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1998. Regulation: 8.