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 K962560
Device Name VITALITY HIP STEM
Applicant
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Applicant Contact ASHLEY M BOCK
Correspondent
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Correspondent Contact ASHLEY M BOCK
Regulation Number888.3350
Classification Product Code
JDI  
Date Received07/01/1996
Decision Date 09/19/1996
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
-
-