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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K151322
Device Name Amendia Interbody Fusion Devices
Applicant
AMENDIA, INC.
1755 WEST OAK PARKWAY
MARIETTA,  GA  30062
Applicant Contact BRUCE HOOPER
Correspondent
AMENDIA, INC.
1755 WEST OAK PARKWAY
MARIETTA,  GA  30062
Correspondent Contact CHELSEA PROFFITT
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received05/18/2015
Decision Date 09/10/2015
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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