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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 K252461
Device Name Swedge™ Pedicle Screw Fixation System Bezier Rod
Applicant
Spinal Resources, Inc.
5975 N. Federal Highway
Suite 250
Fort Lauderdale,  FL  33308
Applicant Contact Bernie Bedor
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3070
Classification Product Code
NKB  
Date Received08/05/2025
Decision Date 01/13/2026
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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