VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0— 510(k) K190545
Substantially EquivalentIcotec AG
FDA 510(k) clearance K190545 for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, Substantially Equivalent on 2019-06-20. Applicant: Icotec AG. Device class: 2.
Clearance details
- Applicant
- Icotec AG
- 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
- 9450 Altstaetten (Sg), CH
Recent devices under product code NKB
view all- 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)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Icotec AG
view all- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
- K242900 — VADER® Pedicle System and VADER®one Pedicle System
- K233215 — icotec Anterior Cervical Plate System
- K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K232790 — KONG®-TL VBR System and KONG® C VBR System
Adverse 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 →
Recalls naming K190545
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.