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FDA 510(k) Application Details - K103533
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K103533
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 BEECH AVENUE
UNIT B6
TORRANCE, CA 90501 US
Other 510(k) Applications for this Company
Contact
JULIE GLENDRANGE
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
12/01/2010
Decision Date
01/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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