The following data is part of a premarket notification filed by Orthosoft D/b/a Zimmer Cas with the FDA for Rosa Partial Knee System.
| Device ID | K210121 |
| 510k Number | K210121 |
| Device Name: | ROSA Partial Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Kavina Veeren |
| Correspondent | Kavina Veeren Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024505230 | K210121 | 000 |
| 00889024594036 | K210121 | 000 |
| 00889024594029 | K210121 | 000 |
| 00889024594012 | K210121 | 000 |
| 00889024594005 | K210121 | 000 |
| 00889024593992 | K210121 | 000 |
| 00889024593985 | K210121 | 000 |