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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 K133036
Device Name APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
Applicant
AMENDIA INC.
11821 BRAMBLE COVE DRIVE
FT. MYERS,  FL  33905
Applicant Contact RICH JANSEN
Correspondent
AMENDIA INC.
11821 BRAMBLE COVE DRIVE
FT. MYERS,  FL  33905
Correspondent Contact RICH JANSEN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/26/2013
Decision Date 03/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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