• 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 K172064
Device Name Ti-Diagon Oblique TLIF
Applicant
Camber Spine Technologies
418 E. Lancaster Avenue
Wayne,  PA  19087
Applicant Contact Daniel Pontecorvo
Correspondent
MCRA, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/07/2017
Decision Date 09/15/2017
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
-
-