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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 K231443
Device Name Mini-OSTEO Pedicle Fixation System
Applicant
Osteomed Indústria E Comércio DE Implantes Ltda
Washington Luis Route, 172 Km - Anhanguera'S Garden
Rio Claro,  BR 13500-970
Applicant Contact Fernando Argenton Neto
Correspondent
Osteomed Indústria E Comércio DE Implantes Ltda
Washington Luis Route, 172 Km - Anhanguera'S Garden
Rio Claro,  BR 13500-970
Correspondent Contact Fernando Argenton Neto
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received05/18/2023
Decision Date 11/21/2023
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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