Mont Blanc and Mont Blanc MIS Spinal Systems— 510(k) K161387
Substantially EquivalentSpineway SA
FDA 510(k) clearance K161387 for Mont Blanc and Mont Blanc MIS Spinal Systems, Substantially Equivalent on 2016-08-04. Applicant: Spineway SA. Device class: 2.
Clearance details
- Applicant
- Spineway SA
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ecully, FR
Recent devices under product code NKB
view all- K262091 — FRAXION Spinal Fixation System
- K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more
- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
More clearances from Spineway SA
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.