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, Smooth
510(k) Number K112675
Device Name ARROW-LOK DIGITAL SYSTEM
Applicant
Arrowhead Medical Device Technologies, LLC
328 Poplar View Ln. E., Suite 2
Collierville,  TN  38017
Applicant Contact THOMAS J TWARDZIK
Correspondent
Arrowhead Medical Device Technologies, LLC
328 Poplar View Ln. E., Suite 2
Collierville,  TN  38017
Correspondent Contact THOMAS J TWARDZIK
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/14/2011
Decision Date 12/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-