The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Iassist Knee System.
| Device ID | K192080 |
| 510k Number | K192080 |
| Device Name: | IASSIST Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Eduardo Mendoza |
| Correspondent | Eduardo Mendoza Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen St., 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 | 2019-08-02 |
| Decision Date | 2019-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024563490 | K192080 | 000 |
| 00889024563483 | K192080 | 000 |