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 Screw, Fixation, Bone
510(k) Number K050346
Device Name STABILIZATION SCREW
Applicant
New Deal, S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
New Deal, S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/11/2005
Decision Date 03/17/2005
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
Recalls CDRH Recalls
-
-