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, Biodegradable, Soft Tissue
510(k) Number K142948
Device Name BIOSURE REGENESORB interference Screw
Applicant
Smith & Nephew, Inc.
150 Minuteman Dr.
Andover,  MA  01810
Applicant Contact Vivek Mukhatyar
Correspondent
Smith & Nephew, Inc.
150 Minuteman Dr.
Andover,  MA  01810
Correspondent Contact Vivek Mukhatyar
Regulation Number888.3030
Classification Product Code
MAI  
Date Received10/10/2014
Decision Date 01/13/2015
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
-
-