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FDA 510(k) Application Details - K162849
Device Classification Name
More FDA Info for this Device
510(K) Number
K162849
Device Name
Huvex Interspinous Fixation System
Applicant
DIO MEDICAL CO., LTD.
101-105 MEGACENTER, SK TECHNOPARK
190-1 SANGDAWON-DONG
JUNGWON-GU SUNGNAM-SI 462-850 KR
Other 510(k) Applications for this Company
Contact
LEE SUNG-HEE
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2016
Decision Date
02/16/2017
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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