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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K232561
Device Name Ripley Spinal Screw System by SAGICO
Applicant
Sagico VA USA, Llc
2189 W Busch Blvd
Tampa,  FL  33612
Applicant Contact James Gibson, PhD, CPA
Correspondent
Sagico VA USA, Llc
2189 W Busch Blvd
Tampa,  FL  33612
Correspondent Contact James Gibson, PhD, CPA
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received08/24/2023
Decision Date 10/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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