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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 NameTOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantWALTER LORENZ SURGICAL, INC.
PMA NumberP020016
Supplement NumberS002
Date Received09/11/2006
Decision Date10/13/2006
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at arthrotek, inc. ?s ontario california, facility for the purchase of raw material for the mandibular blanks; the cutting of this raw material; and the addition of another wire electrical discharge machine.
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