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 Rod, Fixation, Intramedullary And Accessories
510(k) Number K850142
Device Name ACE INTRAMEDULLARY ROD FOR SMALL BONES
Applicant
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/14/1985
Decision Date 02/07/1985
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
-
-