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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
510(k) Number K253374
Device Name LimiFlex® Dynamic Sagittal Tether Instrument Set
Applicant
Empirical Spine
18655 Madrone Pkwy., Suite 180
Morgan Hill,  CA  95037
Applicant Contact Louie Fielding
Correspondent
Empirical Spine
18655 Madrone Pkwy., Suite 180
Morgan Hill,  CA  95037
Correspondent Contact Louie Fielding
Classification Product Code
SGL  
Subsequent Product Code
KCT  
Date Received09/30/2025
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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