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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, Cervical
510(k) Number K161127
Device Name The Small PLATEAU (PLATEAU-C) Spacer System
Applicant
LIFE SPINE INC.
13951 S. Quality Drive
Huntley,  IL  60142
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE INC.
13951 S. Quality Drive
Huntley,  IL  60142
Correspondent Contact RANDY LEWIS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/21/2016
Decision Date 12/22/2016
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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