The following data is part of a premarket notification filed by Orthonovis, Inc. with the FDA for Onx Large External Fixation System.
| Device ID | K213905 |
| 510k Number | K213905 |
| Device Name: | ONX Large External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | OrthoNovis, Inc. 1 Hargrove Grade, 2F Palm Coast, FL 32137 |
| Contact | Ken West |
| Correspondent | Ken West OrthoNovis, Inc. 1 Hargrove Grade, 2F Palm Coast, FL 32137 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-14 |
| Decision Date | 2022-08-25 |