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 hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
510(K) Number K112897
Model A400
Device Name RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
825 nicollet mall
ste 1820
minneapolis,  MN  55402
Contact david a teicher
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
LPH   LZO   OQI  
Date Received10/03/2011
Decision Date 06/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-