
Mandell Horwitz Consultants, LLC
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2GC HIP/KNEE MODULAR SPACER is an FDA 510(k)-cleared medical device (K112470) manufactured by Mandell Horwitz Consultants, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2012. Regulation: 8.