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Ascension Orthopedics, Inc.
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ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 is an FDA 510(k)-cleared medical device (K041451) manufactured by Ascension Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2004. Regulation: 8.