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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 K142230
Device Name Apollo Suture Anchor System and Titan Screws
Applicant
Valeris Medical
200 Cobb Pkw N, Bldg. 200, Suite 210
Marietta,  GA  30062
Applicant Contact Daniel Lanois
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  28408
Correspondent Contact Cheryl L Wagoner
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/13/2014
Decision Date 09/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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