The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Synergy Cranial.
| Device ID | K150216 |
| 510k Number | K150216 |
| Device Name: | Synergy Cranial |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | Kaye E. Waite |
| Correspondent | Kaye E. Waite MEDTRONIC NAVIGATIONS, INC. 826 COAL CREEK CIRCLE Louisville, 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 | 2015-01-30 |
| Decision Date | 2015-06-11 |
| Summary: | summary |