The following data is part of a premarket notification filed by Orthosoft D/b/a Zimmer Cas with the FDA for Rosa Hip System.
| Device ID | K210998 |
| 510k Number | K210998 |
| Device Name: | ROSA Hip System |
| Classification | System, Image Processing, Radiological |
| Applicant | Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Orthosoft D/b/a Zimmer CAS 75 Queen Street, 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 | 2021-04-02 |
| Decision Date | 2021-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024618947 | K210998 | 000 |
| 00887868523915 | K210998 | 000 |
| 00887868523939 | K210998 | 000 |
| 00887868518508 | K210998 | 000 |
| 00887868518515 | K210998 | 000 |
| 00887868518522 | K210998 | 000 |
| 00887868518539 | K210998 | 000 |
| 00887868518546 | K210998 | 000 |
| 00887868518553 | K210998 | 000 |
| 00887868518560 | K210998 | 000 |
| 00887868523885 | K210998 | 000 |
| 00887868525681 | K210998 | 000 |
| 00887868523908 | K210998 | 000 |