
Philips Medical Systems North America, Inc.
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PHILIPS ORTHOPAEDIC APPLICATIONS is an FDA 510(k)-cleared medical device (K042867) manufactured by Philips Medical Systems North America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2004. Regulation: 8.