The following data is part of a premarket notification filed by Spineway S.a. with the FDA for Mont Blanc And Mont Blanc Mis Spinal Systems.
| Device ID | K161387 |
| 510k Number | K161387 |
| Device Name: | Mont Blanc And Mont Blanc MIS Spinal Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEWAY S.A. 7 ALLEE MOULIN BERGER Ecully, FR 69130 |
| Contact | Nicolas Roth |
| Correspondent | Rich Jansen, Pharm.d. RICH JANSEN, PHARM. D. 11821 Bramble Cove Drive Fort Myers, FL 33905 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-19 |
| Decision Date | 2016-08-04 |
| Summary: | summary |