The following data is part of a premarket notification filed by Nanoortho, Llc with the FDA for Nanoortho Nanoknee® System.
| Device ID | K190633 |
| 510k Number | K190633 |
| Device Name: | NanoOrtho NanoKnee® System |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | NanoOrtho, LLC 860 Oak Park Blvd STE 301 Arroyo Grande, CA 93420 |
| Contact | Austin Ferro |
| Correspondent | Andy Rynearson NanoOrtho, LLC 860 Oak Park Blvd STE 301 Arroyo Grande, CA 93420 |
| Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | NJD |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-12 |
| Decision Date | 2019-12-20 |