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FDA 510(k) Application Details - K120464
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K120464
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
BK MEDITECH CO., LTD.
8 EAST BROADWAY, STE 611
SALT LAKE CITY, UT 84111 US
Other 510(k) Applications for this Company
Contact
SHIN KUK YOO
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
02/15/2012
Decision Date
01/18/2013
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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