The following data is part of a premarket notification filed by Spinevision S.a. with the FDA for Lumis Cannulated Pedicle Screw Fixation System, U.l.i.s. Pedicle Screw Fixation System.
| Device ID | K160124 |
| 510k Number | K160124 |
| Device Name: | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SpineVision S.A. 10 Rue De La Renaissance, Batiment E Antony, FR 92160 |
| Contact | Helene Plas |
| Correspondent | Helene Plas SpineVision S.A. 10 Rue De La Renaissance, Batiment E Antony, FR 92160 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-04-04 |
| Summary: | summary |