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 K141004
Device Name INTRAOSSEOUS FIXATION SYSTEM
Applicant
Orthohelix Surgical Designs, Inc.
1065 Medina Rd., Suite 500
Medina,  OH  44256
Applicant Contact BRIAN HOCKETT
Correspondent
Orthohelix Surgical Designs, Inc.
1065 Medina Rd., Suite 500
Medina,  OH  44256
Correspondent Contact BRIAN HOCKETT
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/18/2014
Decision Date 08/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-