
Orthofix, Inc.
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O-Genesis Graft Delivery System is an FDA 510(k)-cleared medical device (K200606) manufactured by Orthofix, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2020. Regulation: 8.

Ansell
SKU MSC846624

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McKesson
SKU VM-1270030

Hollister
SKU VM-1270031