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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 uncemented acetabular component)
510(K) Number K895157
Device Name S.A.F. ACETABULAR CUP
Applicant
SYNERGY ORTHOPAEDICS INTL., INC.
5780 west 71st st.
indianapolis,  IN  46278
Contact kenneth epling
Regulation Number888.3330
Classification Product Code
KWA  
Date Received08/10/1989
Decision Date 12/01/1989
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-