• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 uncemented acetabular component)
510(k) Number K861723
Device Name (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
Original Applicant
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 1677
Original Contact dennis h crane
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/06/1986
Decision Date 06/09/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-