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, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K191449
Device Name ZCA All-Poly Acetabular Cups
Applicant
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Applicant Contact Caleb Barylski
Correspondent
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Correspondent Contact Caleb Barylski
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/31/2019
Decision Date 07/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-