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FDA 510(k) Application Details - K132724
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K132724
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
ICONN ORTHOPEDICS, LLC
400 UNION HILL DR
SUITE 150
BIRMINGHAM, AL 35209 US
Other 510(k) Applications for this Company
Contact
WHITT ISRAEL
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2013
Decision Date
04/17/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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