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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K162351
Device Name SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Applicant Contact Gina Flores
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Correspondent Contact Gina Flores
Regulation Number888.3080
Classification Product Code
OVD  
Date Received08/23/2016
Decision Date 12/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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