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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 K152156
Device Name Opticage Expandable Interbody Fusion Device
Applicant
Interventional Spine, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Applicant Contact Jane Metcalf
Correspondent
Interventional Spine, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Correspondent Contact Jane Metcalf
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/03/2015
Decision Date 10/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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