The following data is part of a premarket notification filed by Spineway with the FDA for Mont Blanc Spinal System.
| Device ID | K150185 |
| 510k Number | K150185 |
| Device Name: | Mont Blanc Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEWAY 7 ALLEE MOULIN BERGER Ecully, FR 69130 |
| Contact | Julien Thao My |
| Correspondent | Rich Jansen RICH JANSEN, PHARM. D. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-05-12 |
| Summary: | summary |