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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 Concepts Patient-Fitted TMJ Reconstruction Prosthesis
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantStryker Leibinger, GmbH & Co KG
Boetzinger Strasse 41, D-7911
Freiburg D-7911
PMA NumberP980052
Supplement NumberS014
Date Received06/04/2024
Decision Date07/30/2024
Product Code LZD 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the addition of an automated thermomechanical bonding machine for bonding of the UHMWPE round bar stock to preformed titanium mesh substrates within the fossa manufacturing process
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