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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 NameCMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantWRIGHT MEDICAL TECHNOLOGY, INC.
PMA NumberN18466
Supplement NumberS019
Date Received09/20/1995
Decision Date11/20/1995
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for cmw 1 radiopaque, cmw2 and cmw3 to be marketed under wright medical as:orthoset 1, orthoset 2, and orthoset 3 bone cement, respectively.
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