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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 K263172
Device Name SAS MIS Pelvic Incidence Rods
Applicant
Spinal Alignment Solutions, Inc.
8044 Market St.
Suite A
Wilmington,  NC  28411
Applicant Contact Bassel Diebo
Correspondent
MRC Global, LLC
9160 Hwy. 64 Suite 12
Lakeland,  TN  38002
Correspondent Contact Christine Scifert
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/10/2026
Decision Date 09/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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