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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.
 
Deviceprodisc C
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS027
Date Received07/05/2024
Decision Date08/07/2024
Product Code MJO 
Advisory Committee Orthopedic
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  
approval allowing (1) both Bricon Technology GmbH and Hammill Medical to machine all inlays used in the prodisc -C, -C Vivo, -C SK, and -C Nova and (2) modification to inlay numbering/identification
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