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, Uncemented
510(k) Number K910664
Device Name MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
Applicant
Medimix Products, Inc.
860 Canal St.
Stamford,  CT  06902
Applicant Contact DEBRA BING
Correspondent
Medimix Products, Inc.
860 Canal St.
Stamford,  CT  06902
Correspondent Contact DEBRA BING
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received02/14/1991
Decision Date 04/01/1992
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
-
-