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 Bone Graft, Lumbar
510(k) Number K172343
Device Name Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
Applicant
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact Diana Taylor
Correspondent
Rti Surgical, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact Diana Taylor
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received08/02/2017
Decision Date 10/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-