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 K112193
Device Name ARROW REVERSE SHOULDER SYSTEM
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact PATRICIA DONNARD
Correspondent
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Correspondent Contact PATRICIA DONNARD
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received07/29/2011
Decision Date 07/12/2012
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
-
-