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 Plate, Bone
510(k) Number K112457
Device Name LEFORTE SYSTEM BONE PLATE & SCREW
Applicant
Arkin Consulting Group
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
Arkin Consulting Group
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/26/2011
Decision Date 05/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-