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 K200368
Device Name LINK Embrace Shoulder System - Reverse Configuration
Applicant
Waldemar Link GmbH & Co. KG
Ostsraße 4-10
Norderstedt,  DE 22844
Applicant Contact Stephanie Fuchs
Correspondent
Link Bio Corp.
69 King Street
Dover,  NJ  07801
Correspondent Contact Terry Powell
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   PAO  
Date Received02/14/2020
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-