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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantNEXUS CMF, LLC
17301 WEST COLFAX AVENUE
SUITE 170
GOLDEN, CO 80401
PMA NumberP000023
Supplement NumberS009
Date Received03/04/2014
Decision Date06/02/2014
Product Code LZD 
Advisory Committee Dental
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED 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.
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