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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K222574
Device Name Simparo Anchor Line Fixation System
Applicant
Simparo, Inc.
1125 Corporate Dr. N.
Mobile,  AL  36607
Applicant Contact Chris Harber
Correspondent
Simparo, Inc.
1125 Corporate Dr. N.
Mobile,  AL  36607
Correspondent Contact Chris Harber
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/25/2022
Decision Date 02/04/2023
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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