The following data is part of a premarket notification filed by Adaptable Ortho Innovations, Llc with the FDA for Adaptable Ortho Innovations Intramedullary Nail System.
| Device ID | K210285 |
| 510k Number | K210285 |
| Device Name: | Adaptable Ortho Innovations Intramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Adaptable Ortho Innovations, LLC 65 Main Street Potsdam, NY 13676 |
| Contact | Steve Palin |
| Correspondent | Kyle Kovach Jalex Medical 27865 Clemens Road, Suite #3 Westlake, OH 44145 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-03-18 |