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 Shoulder Prosthesis, Reverse Configuration
510(k) Number K192855
Device Name DELTA XTEND(TM) Reverse Shoulder System
Applicant
Depuy(Ireland)
Loughbeg Ringaskiddy
Co. Cork,  IE
Applicant Contact Ashley Goncalo
Correspondent
DePuy Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Ashley Goncalo
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received10/04/2019
Decision Date 02/24/2020
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
-
-