The following data is part of a premarket notification filed by Xpandortho, Inc. with the FDA for Xo1 Knee Balancing System.
| Device ID | K162237 |
| 510k Number | K162237 |
| Device Name: | XO1 Knee Balancing System |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | XPANDORTHO, INC. 2223 AVENIDA DE LA PLAYA SUITE 203 La Jolla, CA 92037 -3218 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca Pine XPANDORTHO, INC. 2223 AVENIDA DE LA PLAYA SUITE 203 La Jolla, CA 92037 -3218 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-09 |
| Decision Date | 2017-04-25 |