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 Plate, Fixation, Bone
510(k) Number K113733
Device Name SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
Applicant
Neoortho Produtos Ortopedicos S/A
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
Neoortho Produtos Ortopedicos S/A
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/19/2011
Decision Date 03/23/2012
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
-
-