The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System - S&n Image Free Knee.
| Device ID | K043536 |
| 510k Number | K043536 |
| Device Name: | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-22 |
| Decision Date | 2005-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556074220 | K043536 | 000 |
| 03596010592927 | K043536 | 000 |
| 03596010592903 | K043536 | 000 |
| 03596010592859 | K043536 | 000 |
| 03596010592842 | K043536 | 000 |
| 03596010592835 | K043536 | 000 |
| 03596010592828 | K043536 | 000 |
| 03596010592811 | K043536 | 000 |
| 03596010592804 | K043536 | 000 |
| 03596010592798 | K043536 | 000 |
| 03596010593078 | K043536 | 000 |
| 03596010593054 | K043536 | 000 |
| 03596010592958 | K043536 | 000 |
| 03596010592965 | K043536 | 000 |
| 03596010592972 | K043536 | 000 |
| 00885556074015 | K043536 | 000 |
| 00885556073858 | K043536 | 000 |
| 00885556073841 | K043536 | 000 |
| 00885556073667 | K043536 | 000 |
| 00885556073490 | K043536 | 000 |
| 00885556072875 | K043536 | 000 |
| 00885556072851 | K043536 | 000 |
| 03596010593047 | K043536 | 000 |
| 03596010593016 | K043536 | 000 |
| 03596010592996 | K043536 | 000 |
| 03596010592989 | K043536 | 000 |
| 03596010648174 | K043536 | 000 |