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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K131354
Device Name RENOVIS BIPOLAR HIP SYSTEM
Applicant
Renovis Surgical Technologies, LLC
200 Homer Ave.
Ashland,  MA  0172-
Applicant Contact Sharyn Orton
Correspondent
Renovis Surgical Technologies, LLC
200 Homer Ave.
Ashland,  MA  0172-
Correspondent Contact Sharyn Orton
Regulation Number888.3390
Classification Product Code
KWY  
Date Received05/10/2013
Decision Date 09/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-