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 K133477
Device Name TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
Applicant
Synchro Medical
505 Berks Pl.
West Lawn,  PA  19609
Applicant Contact MARK F SCHENK
Correspondent
Synchro Medical
505 Berks Pl.
West Lawn,  PA  19609
Correspondent Contact MARK F SCHENK
Regulation Number888.3040
Classification Product Code
HTY  
Date Received11/12/2013
Decision Date 02/10/2014
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
-
-