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 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K031449
Device Name MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
Applicant
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact ROBERT A POGGIE
Correspondent
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact ROBERT A POGGIE
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
KWT  
Date Received05/07/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-