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FDA 510(k) Application Details - K152295
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K152295
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
5912 BRECKENRIDGE PARKWAY
SUITE F
TAMPA, FL 33610 US
Other 510(k) Applications for this Company
Contact
Robin Wilson
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
08/13/2015
Decision Date
11/03/2015
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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