The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System - Os Unicondylar Knee Universal, Model# Pro-06003.
| Device ID | K071714 |
| 510k Number | K071714 |
| Device Name: | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 |
| 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 | 2007-06-22 |
| Decision Date | 2007-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024305526 | K071714 | 000 |
| 00889024305519 | K071714 | 000 |
| 00889024305212 | K071714 | 000 |
| 00889024305045 | K071714 | 000 |
| 00889024305038 | K071714 | 000 |
| 00889024305021 | K071714 | 000 |
| 00889024304543 | K071714 | 000 |
| 00889024304536 | K071714 | 000 |
| 00889024211605 | K071714 | 000 |