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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K261271
Device Name Cable-Ready® Cable Grip System
Applicant
Pioneer Surgical Technology, Inc.
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact Sravyalahari Sripada
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact Sravyalahari Sripada
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
HRS   HTN   HWC   KTT  
Date Received04/17/2026
Decision Date 07/16/2026
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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