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FDA 510(k) Application Details - K142121
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K142121
Device Name
Plate, Fixation, Bone
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS, TN 38117 US
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Contact
JEANINE REDDEN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2014
Decision Date
08/21/2014
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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