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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 bone graft, lumbar
510(k) Number K173260
Device Name SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Applicant Contact Gina Flores
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Correspondent Contact Gina Flores
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received10/10/2017
Decision Date 12/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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