The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Signature One System.
| Device ID | K200615 |
| 510k Number | K200615 |
| Device Name: | Signature ONE System |
| Classification | Shoulder Arthroplasty Implantation System |
| Applicant | Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Sankalp Dere |
| Correspondent | Sankalp Dere Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | QHE |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2020-06-05 |