The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Synergy Cranial V2.2.9, Stealthstation Cranial V3.1.4.
| Device ID | K221087 |
| 510k Number | K221087 |
| Device Name: | Synergy Cranial V2.2.9, StealthStation Cranial V3.1.4 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Silver Wirth |
| Correspondent | Silver Wirth Medtronic Navigation, 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 | 2022-04-13 |
| Decision Date | 2022-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000631826 | K221087 | 000 |
| 00763000631765 | K221087 | 000 |
| 00763000631642 | K221087 | 000 |
| 00763000631628 | K221087 | 000 |