The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System-fluorospine, Model 900.005.
| Device ID | K031156 |
| 510k Number | K031156 |
| Device Name: | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 |
| 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 | 2003-04-11 |
| Decision Date | 2003-05-09 |
| Summary: | summary |