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FDA 510(k) Application Details - K133376
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K133376
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
TORNIER, INC.
10801 Nesbitt Avenue South
Bloomington, MN 55437 US
Other 510(k) Applications for this Company
Contact
JANELL A COLLEY
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
11/04/2013
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
Special
Reviewed By Third Party
N
Expedited Review
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