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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K120340
Device Name VENUS FACET SCREW SYSTEM
Applicant
APOLLO SPINE, INC.
75 MILL STREET
STOUGHTON,  MA  02072
Applicant Contact CHRISTINE SANTAGATE
Correspondent
APOLLO SPINE, INC.
75 MILL STREET
STOUGHTON,  MA  02072
Correspondent Contact CHRISTINE SANTAGATE
Classification Product Code
MRW  
Date Received02/03/2012
Decision Date 10/19/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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