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FDA 510(k) Application Details - K143204
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K143204
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3203 KASHIWA STREET
TORRANCE, CA 90505 US
Other 510(k) Applications for this Company
Contact
ANNA HWANG
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
11/07/2014
Decision Date
06/03/2015
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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