The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Navitrack System: Total Hip Replacement Ct-free Cup, Model 900.204.
| Device ID | K030827 |
| 510k Number | K030827 |
| Device Name: | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024305205 | K030827 | 000 |
| 00889024304857 | K030827 | 000 |
| 00889024304840 | K030827 | 000 |
| 00889024304796 | K030827 | 000 |
| 00889024304789 | K030827 | 000 |
| 00889024304772 | K030827 | 000 |
| 00889024304765 | K030827 | 000 |
| 00889024304581 | K030827 | 000 |
| 00889024304574 | K030827 | 000 |
| 00889024304567 | K030827 | 000 |
| 00889024304239 | K030827 | 000 |
| 00889024304222 | K030827 | 000 |
| 00889024304215 | K030827 | 000 |
| 00889024304208 | K030827 | 000 |
| 00889024304864 | K030827 | 000 |
| 00889024304871 | K030827 | 000 |
| 00889024305120 | K030827 | 000 |
| 00889024305113 | K030827 | 000 |
| 00889024305106 | K030827 | 000 |
| 00889024305090 | K030827 | 000 |
| 00889024305083 | K030827 | 000 |
| 00889024305014 | K030827 | 000 |
| 00889024304970 | K030827 | 000 |
| 00889024304956 | K030827 | 000 |
| 00889024304949 | K030827 | 000 |
| 00889024304918 | K030827 | 000 |
| 00889024304901 | K030827 | 000 |
| 00889024304895 | K030827 | 000 |
| 00889024304888 | K030827 | 000 |
| 00889024304192 | K030827 | 000 |