The following data is part of a premarket notification filed by Orthosoft D/b/a Zimmer Cas with the FDA for Iassist Knee System.
| Device ID | K213033 |
| 510k Number | K213033 |
| Device Name: | IASSIST Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868558474 | K213033 | 000 |
| 00887868558467 | K213033 | 000 |
| 00887868540509 | K213033 | 000 |
| 00887868519017 | K213033 | 000 |