SMALL BONE FIXATION SYSTEM
Pin, Fixation, Smooth
HAND INNOVATIONS, INC.
The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Small Bone Fixation System.
Pre-market Notification Details
| Device ID | K033406 |
| 510k Number | K033406 |
| Device Name: | SMALL BONE FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | HAND INNOVATIONS, INC. 8905 SW 87TH AVE. Miami, FL 33176 -2227 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn HAND INNOVATIONS, INC. 8905 SW 87TH AVE. Miami, FL 33176 -2227 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2004-01-15 |
| Summary: | summary |
Trademark Results [SMALL BONE FIXATION SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMALL BONE FIXATION SYSTEM 78784347 not registered Dead/Abandoned |
Small Bone Innovations, LLC 2006-01-03 |
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