The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrak System-optical Option, Model 900.004.
| Device ID | K002053 |
| 510k Number | K002053 |
| Device Name: | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ORTHOSOFT, INC. 80 QUEEN ST., SUITE 604 Montreal, Quebec, CA H3c 2n5 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville ORTHOSOFT, INC. 80 QUEEN ST., SUITE 604 Montreal, Quebec, CA H3c 2n5 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-06 |
| Decision Date | 2000-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024304598 | K002053 | 000 |
| 00889024304291 | K002053 | 000 |