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FDA 510(k) Application Details - K142041
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K142041
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
POROSTEON, INC.
100 PROMENADE SAINT LOUIS
NOTRE-DAME-DE-L'LLE-PERROT,QUEBEC J7V 7P2 CA
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Contact
ROBERT A POGGIE, PHD
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
07/28/2014
Decision Date
12/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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