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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 K152501
Device Name Spinal Jaxx Interbody Fusion Device
Applicant
Neuropro Spinaljaxx, Inc.
4707 Greenleaf Ct., Suite C
Modesto,  CA  95356
Applicant Contact BENJAMIN J. REMINGTON
Correspondent
Silver Pine Consulting, LLC
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact RICH JANSEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/01/2015
Decision Date 06/29/2016
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
Recalls CDRH Recalls
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