The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine & Trauma Navigation.
| Device ID | K191285 |
| 510k Number | K191285 |
| Device Name: | Spine & Trauma Navigation |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Julia Mehltretter |
| Correspondent | Julia Mehltretter Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-06-11 |