The following data is part of a premarket notification filed by Zimmer Cas with the FDA for Iassist Knee System.
| Device ID | K141601 |
| 510k Number | K141601 |
| Device Name: | IASSIST KNEE SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ZIMMER CAS 75 QUEEN STREET, SUITE 3300 Montreal, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ZIMMER CAS 75 QUEEN STREET, SUITE 3300 Montreal, CA H3c 2n6 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024492721 | K141601 | 000 |
| 00889024492714 | K141601 | 000 |
| 00889024492707 | K141601 | 000 |
| 00889024492691 | K141601 | 000 |
| 00889024305250 | K141601 | 000 |
| 00889024211636 | K141601 | 000 |