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 System, Facet Screw Spinal Device
510(k) Number K120340
Device Name VENUS FACET SCREW SYSTEM
Applicant
Apollo Spine, Inc.
75 Mill St.
Stoughton,  MA  02072
Applicant Contact CHRISTINE SANTAGATE
Correspondent
Apollo Spine, Inc.
75 Mill St.
Stoughton,  MA  02072
Correspondent Contact CHRISTINE SANTAGATE
Classification Product Code
MRW  
Date Received02/03/2012
Decision Date 10/19/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-