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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.
 
DeviceBAGUERA®C Cervical Disc Prosthesis
Generic NameProsthesis, intervertebral disc
ApplicantSpineart USA, Inc.
23332 Mill Creek Dr.
Suite 150
Laguna Hills, CA 92653
PMA NumberP250042
Supplement NumberS002
Date Received08/26/2026
Decision Date09/22/2026
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT04520776
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250042
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