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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameglenoid fossa prosthesis
Regulation Number872.3950
PMA NumberP000035
Supplement NumberS009
Date Received03/06/2014
Decision Date06/02/2014
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the bone screw length to match the labeled lengths, to standardize the screw thread profile and pitch, to increase the length of the threaded portion of the bone screw, to round the tip of the screw, to add a fillet between the screw head and screw shaft, to standardize dimensions of certain geometrical features of the bone screws (the screw head crown radius and driver slot depth), to standardize the minor diameter, and to introduce ti-6al-4v alloy bone screws.