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 K223211
Device Name INHANCETM Shoulder System – Humeral Stems and Stemless
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Yayoi Fujimaki
Correspondent
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Correspondent Contact Russ Parrott
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   KWT   MBF   PAO  
PKC  
Date Received10/17/2022
Decision Date 12/02/2022
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
-
-