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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K171156
Device Name OMNI Anseris Hip Stem
Applicant
OMNIlife science
480 Paramount Drive
Raynham,  MA  02767
Applicant Contact Christina Rovaldi
Correspondent
OMNIlife science
480 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Christina Rovaldi
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LWJ  
Date Received04/20/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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