
OrthoPediatrics Corp.
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RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System is an FDA 510(k)-cleared medical device (K193100) manufactured by OrthoPediatrics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2020. Regulation: 8.

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SKU K100676
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SKU VM-1270020

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