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FDA 510(k) Application Details - K150223
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K150223
Device Name
System, Facet Screw Spinal Device
Applicant
FACET-LINK, INC.
101 ROUNDHILL DRIVE, 2ND FLOOR
ROCKAWAY, NJ 07866 US
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Contact
Massimo Calafiore
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2015
Decision Date
04/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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