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 Arthroplasty Implantation System
510(k) Number K192074
Device Name Signature ONE System
Applicant
Orthosoft Inc (D/B/A Zimmer Cas)
75 Queen St. Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Paul Hardy
Correspondent
Orthosoft Inc (D/B/A Zimmer Cas)
75 Queen St. Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Paul Hardy
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   KWT   MBF   PHX  
Date Received08/02/2019
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-