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 K163269
Device Name Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
Applicant
TITAN SPINE, LLC
6140 W. EXECUTIVE DR
STE A
MEQUON,  WI  53092
Applicant Contact JANE RODD
Correspondent
MRC-X, LLC
3416 ROXEE RUN COVE
BARTLETT,  TN  38133
Correspondent Contact CHRISTINE SCIFERT
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/21/2016
Decision Date 04/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-