The following data is part of a premarket notification filed by Laura Cattabriga with the FDA for Cannulated Screw And Kirschner (kwire) System.
| Device ID | K130613 |
| 510k Number | K130613 |
| Device Name: | CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village, FL 33141 |
| Contact | Laura Cattabriga |
| Correspondent | Laura Cattabriga LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village, FL 33141 |
| Product Code | HWC |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2014-01-22 |
| Summary: | summary |