The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System-os Knee Universal, Model Pro-05002.
| Device ID | K060336 |
| 510k Number | K060336 |
| Device Name: | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 |
| 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 | 2006-02-10 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024304727 | K060336 | 000 |
| 00889024304482 | K060336 | 000 |
| 00889024304475 | K060336 | 000 |
| 00889024304468 | K060336 | 000 |
| 00889024304451 | K060336 | 000 |
| 00889024304444 | K060336 | 000 |
| 00889024304437 | K060336 | 000 |
| 00889024304420 | K060336 | 000 |
| 00889024304413 | K060336 | 000 |
| 00889024304406 | K060336 | 000 |
| 00889024304369 | K060336 | 000 |
| 00889024304352 | K060336 | 000 |
| 00889024304345 | K060336 | 000 |
| 00889024304338 | K060336 | 000 |
| 00889024304321 | K060336 | 000 |
| 00889024304499 | K060336 | 000 |
| 00889024304505 | K060336 | 000 |
| 00889024304710 | K060336 | 000 |
| 00889024304383 | K060336 | 000 |
| 00889024304376 | K060336 | 000 |
| 00889024304314 | K060336 | 000 |
| 00889024492769 | K060336 | 000 |
| 00889024492752 | K060336 | 000 |
| 00889024304734 | K060336 | 000 |
| 00889024304697 | K060336 | 000 |
| 00889024304680 | K060336 | 000 |
| 00889024304673 | K060336 | 000 |
| 00889024304666 | K060336 | 000 |
| 00889024304659 | K060336 | 000 |
| 00889024304529 | K060336 | 000 |
| 00889024304512 | K060336 | 000 |
| 00889024304307 | K060336 | 000 |