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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.
 
Trade NameORTHOSET BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantWRIGHT MEDICAL TECHNOLOGY, INC.
PMA NumberN18466
Supplement NumberS023
Date Received10/01/1998
Decision Date10/21/1998
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your orthoset 1, orthoset 2, and orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.
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