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Ge Healthcare Technologies
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GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 is an FDA 510(k)-cleared medical device (K051734) manufactured by Ge Healthcare Technologies. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 2005. Regulation: 8.