The following data is part of a premarket notification filed by Hand Innovations, Inc. with the FDA for Intramedullary Fixation System For The Hand.
| Device ID | K013424 |
| 510k Number | K013424 |
| Device Name: | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-12-20 |
| Summary: | summary |