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 plate, fixation, bone
510(k) Number K192021
Device Name NCB Polyaxial Locking Plate System
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Annemie Rehor Kausch
Correspondent
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Danielle Jannuzzi Madureira
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/29/2019
Decision Date 08/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-