The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Trochanteric Im Nail System.
| Device ID | K150769 |
| 510k Number | K150769 |
| Device Name: | Cardinal Health Trochanteric IM Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. Waukegan, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Kyungyoon Kang Cardinal Health 720 S. Colorado Blvd, Suite 550S Denver, CO 80246 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-12-14 |
| Summary: | summary |