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 K202611
Device Name Catalyst OrthoScience R1 Reverse Shoulder System
Applicant
Catalyst Orthoscience, Inc.
14710 Tamiami Trl. N.
Naples,  FL  34110
Applicant Contact Dale Davison
Correspondent
Catalyst Orthoscience, Inc.
14710 Tamiami Trl. N.
Naples,  FL  34110
Correspondent Contact Dale Davison
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
HSD  
Date Received09/09/2020
Decision Date 02/12/2021
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
-
-