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FDA 510(k) Application Details - K142602
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K142602
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS, TN 38117 US
Other 510(k) Applications for this Company
Contact
VAL MYLES
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
09/15/2014
Decision Date
10/22/2014
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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