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 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K190633
Device Name NanoOrtho NanoKnee® System
Applicant
Nanoortho, LLC
860 Oak Park Blvd. Suite 301
Arroyo Grande,  CA  93420
Applicant Contact Austin Ferro
Correspondent
Nanoortho, LLC
860 Oak Park Blvd. Suite 301
Arroyo Grande,  CA  93420
Correspondent Contact Andy Rynearson
Regulation Number888.3530
Classification Product Code
HRY  
Subsequent Product Codes
HSX   NJD  
Date Received03/12/2019
Decision Date 12/20/2019
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
-
-