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 K121312
Device Name INTRAMEDULLARY NAIL SYSTEM
Applicant
Weigao Orthopaedic Device Co., Ltd.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Weigao Orthopaedic Device Co., Ltd.
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/01/2012
Decision Date 10/24/2012
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
-
-