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 K940307
Device Name HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact MARY C SPICER
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact MARY C SPICER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/24/1994
Decision Date 01/19/1995
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
Recalls CDRH Recalls
-
-