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FDA 510(k) Application Details - K162220
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K162220
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
DIO MEDICAL CO., LTD
101-105 MEGACENTER, SK TECHNOPARK,
SAGIMAKGOL-RO JUNGWON-GU SEONGNAM-SI 124 KR
Other 510(k) Applications for this Company
Contact
SUNG HEE-LEE
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
ODP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2016
Decision Date
11/21/2016
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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