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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.
 
DeviceLimiFlex™ Dynamic Sagittal Tether
Generic NameProsthesis, spinous process tension band implant
ApplicantEmpirical Spine, Inc.
18655 Madrone Pkwy., Suite 180
Morgan Hill, CA 95037
PMA NumberP220031
Supplement NumberS001
Date Received03/12/2026
Decision Date04/08/2026
Product Code SGK 
Advisory Committee Orthopedic
Clinical TrialsNCT03115983
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  
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 P220031
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