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 Rod, Fixation, Intramedullary And Accessories
510(k) Number K142451
Device Name OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Applicant
Merete Medical GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical, Inc.
4 Crotty Lane-Suite 118, New York International Plaza
New Windsor,  NY  12553
Correspondent Contact RUDIGER HILKEN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/02/2014
Decision Date 02/09/2015
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
-
-