The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System - S&n Image Free Hip, Model Pro-03017.
| Device ID | K041369 |
| 510k Number | K041369 |
| Device Name: | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 |
| 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 | 2004-05-24 |
| Decision Date | 2004-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23596010544111 | K041369 | 000 |