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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 Temporomandibular Joint (TMJ) Reconstruction Prosthesis System
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantStryker Leibinger, GmbH & Co KG
Boetzinger Strasse 41, D-7911
Freiburg D-7911
PMA NumberP980052
Supplement NumberS016
Date Received06/23/2025
Decision Date07/23/2025
Product Code LZD 
Advisory Committee Dental
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to modify the method of inspection of the articular surface of the Fossa component to utilize the MarSurf CM Explorer Microscope
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