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FDA 510(k) Application Details - K131609
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K131609
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD
NO. 218, HOUXIANG ROAD
HAICANG DISTRICT
XIAMEN, FUJIAN 361022 CN
Other 510(k) Applications for this Company
Contact
DA ZENG
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
06/03/2013
Decision Date
05/21/2014
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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