The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Bone Fixation Wire (kirschner Wire).
| Device ID | K073674 |
| 510k Number | K073674 |
| Device Name: | BONE FIXATION WIRE (KIRSCHNER WIRE) |
| Classification | Pin, Fixation, Smooth |
| Applicant | SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-03-24 |
| Summary: | summary |