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FDA 510(k) Application Details - K141284
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K141284
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG, VA 20175 US
Other 510(k) Applications for this Company
Contact
NANCY GIEZEN
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
05/16/2014
Decision Date
07/23/2014
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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