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 K201267
Device Name Adaptix Interbody System with Titan nanoLOCK Surface Technology
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Diamond Wallace
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Diamond Wallace
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OLO  
Date Received05/12/2020
Decision Date 08/26/2020
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
-
-