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, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K112556
Device Name ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact VALERIE GIAMBANCO
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact VALERIE GIAMBANCO
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received09/02/2011
Decision Date 09/28/2011
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
Recalls CDRH Recalls
-
-