The following data is part of a premarket notification filed by Zimvie (zimmer Biomet Spine, Inc.) with the FDA for Vital Navigation System.
| Device ID | K213720 |
| 510k Number | K213720 |
| Device Name: | Vital Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ZimVie (Zimmer Biomet Spine, Inc.) 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Hanna Aucoin |
| Correspondent | Hanna Aucoin ZimVie (Zimmer Biomet Spine, Inc.) 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-24 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663055468 | K213720 | 000 |
| 03662663055345 | K213720 | 000 |
| 03662663055338 | K213720 | 000 |
| 03662663055321 | K213720 | 000 |
| 03662663055314 | K213720 | 000 |
| 03662663055307 | K213720 | 000 |
| 03662663055291 | K213720 | 000 |
| 03662663055284 | K213720 | 000 |
| 03662663055277 | K213720 | 000 |
| 03662663055352 | K213720 | 000 |
| 03662663055369 | K213720 | 000 |
| 03662663055376 | K213720 | 000 |
| 03662663055451 | K213720 | 000 |
| 03662663055444 | K213720 | 000 |
| 03662663055437 | K213720 | 000 |
| 03662663055420 | K213720 | 000 |
| 03662663055413 | K213720 | 000 |
| 03662663055406 | K213720 | 000 |
| 03662663055390 | K213720 | 000 |
| 03662663055383 | K213720 | 000 |
| 03662663055260 | K213720 | 000 |