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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 K133286
Device Name MIDLINE (TM)
Applicant
Centinel Spine, Inc.
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Applicant Contact JOHN PARRY
Correspondent
Centinel Spine, Inc.
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Correspondent Contact JOHN PARRY
Regulation Number888.3080
Classification Product Code
OVD  
Date Received10/25/2013
Decision Date 01/09/2014
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
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