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FDA 510(k) Application Details - K081906
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K081906
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
GLOBUS MEDICAL, INC.
2560 GENERAL ARMISTEAD AVE.
VALLEY FORGE BUSINESS CENTER
AUDUBON, PA 19403 US
Other 510(k) Applications for this Company
Contact
KELLY J BAKER
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2008
Decision Date
11/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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