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 K042440
Device Name ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
Applicant
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN YARNALL
Correspondent
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact ELLEN YARNALL
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/09/2004
Decision Date 10/07/2004
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
-
-