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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K181607
Device Name Thorecon Rigid Fixation System
Applicant
A&E Medical Corporation
5206 Asbury Road, PO Box 758
Farmingdale,  NJ  07727
Applicant Contact Dana Rodriguez
Correspondent
RTI Surgical, Inc
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Sarah Pleaugh
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
GAQ   HRS   HWC  
Date Received06/19/2018
Decision Date 10/12/2018
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
Recalls CDRH Recalls
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