Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Dr.
Fr. 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
-
-