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FDA 510(k) Application Details - K113828
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K113828
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
MEDSHAPE, INC
1575 NORTHSIDE DRIVE,
SUITE 440
ATLANTA, GA 30318 US
Other 510(k) Applications for this Company
Contact
JEREMY BLAIR
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2011
Decision Date
02/29/2012
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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