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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
Original Applicant
Valeris Medical
200 cobb pkw n,bldg 200 ste 210
marietta,  GA  30062
Original Contact daniel lanois
Regulation Number888.3040
Classification Product Code
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