
K2m
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Brainlab Compatible K2M Navigation Instruments is an FDA 510(k)-cleared medical device (K181890) manufactured by K2m. 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 8, 2018. Regulation: 8.

ADC
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Welch Allyn
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