Mont Blanc MIS Spinal Systems 1
Mont Blanc MIS Spinal Systems 1 (MIS1PSC650) is a Class II device made by Spineway SA, cleared under FDA 510(k) K161387 on 4 Aug 2016 and listed in FDA GUDID since 8 Aug 2016 (UDI-DI 03663422080196), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03663422080196 | Date8 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161387 | Date4 Aug 2016 | StatusActive |
Official records
- AccessGUDID record 03663422080196
- FDA 510(k) database K161387
Across registries
- FDA 510(k) K161387 decided 4 Aug 2016 Active
- FDA GUDID UDI-DI 03663422080196 listed 8 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K161387
- Listed FDA GUDID 03663422080196
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mont Blanc MIS Spinal Systems
- Generic name
- Bone-screw internal spinal fixation system, sterile
- Model / Ref / Catalog
- 1, MIS1PSC650
- Primary DI / UDI-DI
- 03663422080196
- 510(k) Number
- FDA product code
- NKB, MNI, MNH, KWP, OSH
- GMDN term
- Bone-screw internal spinal fixation system, sterile
- Device class
- Class II
- Regulation number
- 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 6 MillimeterLength — 50 Millimeter
Similar devices in this category
Other devices filed under Bone-screw internal spinal fixation system, sterile.