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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 K151312
Device Name VerteLP Interbody Fusion Device
Applicant
VGI, LLC
150 253rd Ave
St. Petersburg,  FL  33708
Applicant Contact Tov Vestgaarten
Correspondent
Silver Pine Consulting, LLC.
11821 Bramble Cove Drive
Ft. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3080
Classification Product Code
OVD  
Date Received05/18/2015
Decision Date 01/13/2016
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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