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, Cemented
510(k) Number K952629
Device Name NEXFLEX TOTAL HIP SYSTEM
Applicant
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Applicant Contact BRADFORD D DAVIS
Correspondent
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Correspondent Contact BRADFORD D DAVIS
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received06/08/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-