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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, Cervical
510(k) Number K142041
Device Name POROSTEON PHUSION METAL CERVICAL CAGE
Applicant
Porosteon, Inc.
100 Promenade Saint Louis
Notre-Dame-De-L'Lle-Perrot,Quebec,  CA J7V 7P2
Applicant Contact ROBERT A POGGIE, PHD
Correspondent
Porosteon, Inc.
100 Promenade Saint Louis
Notre-Dame-De-L'Lle-Perrot,Quebec,  CA J7V 7P2
Correspondent Contact ROBERT A POGGIE, PHD
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/28/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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