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FDA 510(k) Application Details - K130467
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K130467
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
MEDSHAPE, INC
1575 NORTHSIDE DRIVE NW
SUITE 440
ATLANTA, GA 30318 US
Other 510(k) Applications for this Company
Contact
KENNETH M DUPONT, PH.D.
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
02/25/2013
Decision Date
12/05/2013
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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