The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Medtronic Orthopaedic Trauma Application.
| Device ID | K050651 |
| 510k Number | K050651 |
| Device Name: | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, CO 80027 |
| Contact | Tina Dreiling |
| Correspondent | Tina Dreiling MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-07-27 |
| Summary: | summary |