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FDA 510(k) Application Details - K132765
Device Classification Name
More FDA Info for this Device
510(K) Number
K132765
Device Name
PFX SPINOUS PROCESS FIXATION SYSTEM
Applicant
INNOVASIS, INC.
614 EAST 3900 SOUTH
SALT LAKE CITY, UT 84107 US
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Contact
MARSHALL MCCARTY
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2013
Decision Date
07/14/2014
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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