The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Vital Navigation System.
| Device ID | K191722 |
| 510k Number | K191722 |
| Device Name: | Vital Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Zimmer Biomet Spine, Inc. 10225 Westminster Drive Westminster, CO 80021 |
| Contact | Alex Pawlowski |
| Correspondent | Alex Pawlowski Zimmer Biomet Spine, Inc. 10225 Westminster Drive Westminster, CO 80021 |
| Product Code | OLO |
| Subsequent Product Code | HAW |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-27 |
| Decision Date | 2019-12-02 |