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 |