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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 K243259
Device Name MASADA Modular Spinal Fixation System
Applicant
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Applicant Contact Parker Kelch
Correspondent
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Correspondent Contact Parker Kelch
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   OLO   OWI  
Date Received10/15/2024
Decision Date 01/07/2025
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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