The following data is part of a premarket notification filed by Bioduct, Llc with the FDA for Bioduct.
Device ID | K053492 |
510k Number | K053492 |
Device Name: | BIODUCT |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | BIODUCT, LLC 3201 STELLHORN ROAD Fort Wayne, IN 46815 |
Contact | Herb Schwartz |
Correspondent | Herb Schwartz BIODUCT, LLC 3201 STELLHORN ROAD Fort Wayne, IN 46815 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-15 |
Decision Date | 2007-04-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIODUCT 78840098 3371080 Dead/Cancelled |
HOWMEDICA OSTEONICS CORP. 2006-03-17 |
![]() BIODUCT 77326149 3593815 Dead/Cancelled |
Howmedica Osteonics Corp. 2007-11-09 |