The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health External Fixation System.
| Device ID | K150579 |
| 510k Number | K150579 |
| Device Name: | Cardinal Health External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | CARDINAL HEALTH 1500 Waukegan Rd Waukegan, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Tatyana Bogdan CARDINAL HEALTH 1500 Waukegan Rd Waukegan, IL 60085 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-04-29 |
| Summary: | summary |