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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 K160464
Device Name Opticage(R) Expandable Interbody Fusion Device
Applicant
INTERVENTIONAL SPINE, INC.
13700 ALTON PARKWAY
SUITE 160
IRVINE,  CA  92618
Applicant Contact JANE METCALF
Correspondent
INTERVENTIONAL SPINE, INC.
13700 ALTON PARKWAY
SUITE 160
IRVINE,  CA  92618
Correspondent Contact JANE METCALF
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/19/2016
Decision Date 04/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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