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FDA 510(k) Application Details - K122378
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K122378
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
BIOMET SPINE (AKA EBI, LLC)
100 INTERPACE PARKWAY
PARSIPPANY, NJ 07054 US
Other 510(k) Applications for this Company
Contact
VIVIAN KELLY
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
08/06/2012
Decision Date
09/20/2012
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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