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FDA 510(k) Application Details - K141897
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K141897
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SYNTHES USA PRODUCTS, LLC
325 PARAMOUNT DRIVE
RAYHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
MITCH OHIWA
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
07/14/2014
Decision Date
09/25/2014
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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