The following data is part of a premarket notification filed by B-one Ortho Corp. with the FDA for B-one Total Knee System.
| Device ID | K180446 |
| 510k Number | K180446 |
| Device Name: | B-ONE Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | b-One Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 |
| Contact | Allison Gecik |
| Correspondent | Allison Gecik b-One Ortho Corp 3 Wing Drive Suite #259 Cedar Knolls, NJ 07929 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-10-12 |
| Summary: | summary |