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 Posterior Cervical Screw System
510(k) Number K210449
Device Name Infinity™ OCT System, PASS OCT® Spinal System
Applicant
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Shweta Sharma
Correspondent
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Shweta Sharma
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received02/16/2021
Decision Date 03/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-