The following data is part of a premarket notification filed by Spineway Sa with the FDA for Mont Blanc & Mont Blanc Mis Spinal Systems.
| Device ID | K191726 |
| 510k Number | K191726 |
| Device Name: | Mont Blanc & Mont Blanc MIS Spinal Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spineway SA 7 Allee Moulin Berger Ecully, FR 69130 |
| Contact | Heloise Macaire |
| Correspondent | Tamala J. Wampler Novus Management Group LLC 6686 Dimmick Road West Chester, OH 45069 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-27 |
| Decision Date | 2019-09-12 |
| Summary: | summary |