BIODUCT
Fastener, Fixation, Biodegradable, Soft Tissue
BIODUCT, LLC
The following data is part of a premarket notification filed by Bioduct, Llc with the FDA for Bioduct.
Pre-market Notification Details
| 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 |
Trademark Results [BIODUCT]
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 |
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