The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Zimmer Biomet Universal Navigation System.
| Device ID | K190556 |
| 510k Number | K190556 |
| Device Name: | Zimmer Biomet Universal Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Kelly Stratton |
| Correspondent | Alex Pawlowski Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-10-24 |
| Summary: | summary |