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 K895173
Device Name SKELETAL FIXATION PIN
Applicant
Kronner Medical
544 W. Umpqua
Suite 104
Roseburg,  OR  97470
Correspondent
Kronner Medical
544 W. Umpqua
Suite 104
Roseburg,  OR  97470
Regulation Number888.3040
Classification Product Code
JDW  
Date Received08/10/1989
Decision Date 09/12/1989
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
-
-