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 K051075
Device Name ENCORE REVERSE SHOULDER PROSTHESIS
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact CHRISTIE SHUMAKER
Correspondent
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact CHRISTIE SHUMAKER
Regulation Number888.3660
Classification Product Code
PHX  
Date Received04/27/2005
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-