The following data is part of a premarket notification filed by Zimmer Cas with the FDA for Navitrack System - Os Knee Universal, Cas Same Incision Tibia Reference.
| Device ID | K110054 |
| 510k Number | K110054 |
| Device Name: | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ZIMMER CAS 75 QUEEN STREET SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ZIMMER CAS 75 QUEEN STREET SUITE 3300 Montreal, Quebec, 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 | 2011-01-07 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024479012 | K110054 | 000 |
| 00889024304758 | K110054 | 000 |
| 00889024478954 | K110054 | 000 |
| 00889024478961 | K110054 | 000 |
| 00889024478978 | K110054 | 000 |
| 00889024485518 | K110054 | 000 |
| 00889024488502 | K110054 | 000 |
| 00889024489165 | K110054 | 000 |
| 00889024492646 | K110054 | 000 |
| 00889024492738 | K110054 | 000 |
| 00889024492745 | K110054 | 000 |
| 00889024304390 | K110054 | 000 |
| 00889024479005 | K110054 | 000 |
| 00889024304741 | K110054 | 000 |