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FDA 510(k) Application Details - K081230
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K081230
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
LANE 999, ZHONGSHAN NO. 2 ROAD
SUITE 8D, NO. 19
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
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
04/30/2008
Decision Date
01/13/2009
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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