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 K053492
Device Name BIODUCT
Applicant
Bioduct, LLC
3201 Stellhorn Rd.
Fort Wayne,  IN  46815
Applicant Contact HERB SCHWARTZ
Correspondent
Bioduct, LLC
3201 Stellhorn Rd.
Fort Wayne,  IN  46815
Correspondent Contact HERB SCHWARTZ
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/15/2005
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
-
-