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 K060072
Device Name MONOBLOCK PRESS-FIT HIP STEM
Applicant
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
SUITE 302
RAYNHAM,  MA  02767
Applicant Contact EDWARD J CHEAL
Correspondent
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
SUITE 302
RAYNHAM,  MA  02767
Correspondent Contact EDWARD J CHEAL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received01/09/2006
Decision Date 08/24/2006
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
-
-