BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD is an FDA 510(k)-cleared medical device (K953045) manufactured by Biologically Oriented Prostheses. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 1995. Regulation: 8.