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 Pin, Fixation, Threaded
510(k) Number K960023
Device Name KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
Applicant
Promex, Inc.
1125 Brookside Ave.
Suite G500
Indianapolis,  IN  46202
Applicant Contact JOSEPH L MARK
Correspondent
Promex, Inc.
1125 Brookside Ave.
Suite G500
Indianapolis,  IN  46202
Correspondent Contact JOSEPH L MARK
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received01/02/1996
Decision Date 03/18/1996
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
-
-