• 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, fixation, bone
510(k) Number K142135
Device Name REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
Applicant
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
6 MARS COURT, UNIT 6-3
BOONTON,  NJ  07005
Applicant Contact JAN TRIANI
Correspondent
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
6 MARS COURT, UNIT 6-3
BOONTON,  NJ  07005
Correspondent Contact JAN TRIANI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/04/2014
Decision Date 08/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-