The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Rosa Knee System.
| Device ID | K182964 |
| 510k Number | K182964 |
| Device Name: | ROSA Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Ste. 3300 Montreal, CA H3c 2n6 |
| Contact | Eric Desrosiers |
| Correspondent | Eric Desrosiers Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Ste. 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 | 2018-10-25 |
| Decision Date | 2019-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024584426 | K182964 | 000 |
| 00889024505254 | K182964 | 000 |
| 00889024505230 | K182964 | 000 |
| 00889024505223 | K182964 | 000 |
| 00889024505216 | K182964 | 000 |
| 00889024505209 | K182964 | 000 |
| 00889024505193 | K182964 | 000 |
| 00889024505186 | K182964 | 000 |
| 00889024505179 | K182964 | 000 |
| 00889024505155 | K182964 | 000 |
| 00889024511026 | K182964 | 000 |
| 00889024511170 | K182964 | 000 |
| 00889024511323 | K182964 | 000 |
| 00889024584419 | K182964 | 000 |
| 00889024516823 | K182964 | 000 |
| 00889024516816 | K182964 | 000 |
| 00889024516809 | K182964 | 000 |
| 00889024516793 | K182964 | 000 |
| 00889024516786 | K182964 | 000 |
| 00889024511354 | K182964 | 000 |
| 00889024511347 | K182964 | 000 |
| 00889024511330 | K182964 | 000 |
| 00889024505148 | K182964 | 000 |