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, Metal/Polymer, Porous Uncemented
510(k) Number K113242
Device Name APEX ARC HIP STEM
Applicant
Omni Life Science, Inc.
50 O'Connell Way
East Taunton,  MA  02718
Applicant Contact CHRISTINE NASSIF
Correspondent
Omni Life Science, Inc.
50 O'Connell Way
East Taunton,  MA  02718
Correspondent Contact CHRISTINE NASSIF
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO   MEH  
Date Received11/02/2011
Decision Date 01/05/2012
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
-
-