The following data is part of a premarket notification filed by Orthosoft, Inc. (d/b/a Zimmer Cas) with the FDA for Optivu Rosa Mxr.
| Device ID | K220733 |
| 510k Number | K220733 |
| Device Name: | OptiVu ROSA MxR |
| Classification | System, Image Processing, Radiological |
| Applicant | Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, CA H3C 2N6 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, CA H3C 2N6 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868554490 | K220733 | 000 |
| 00887868554483 | K220733 | 000 |