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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K070167
Device Name ENDOBUTTON DIRECT
Applicant
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DEANA BOUSHELL
Correspondent
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DEANA BOUSHELL
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received01/18/2007
Decision Date 04/12/2007
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
-
-