VADER® Pedicle System, G21 Cement— 510(k) K222789
Substantially EquivalentIcotec AG
FDA 510(k) clearance K222789 for VADER® Pedicle System, G21 Cement, Substantially Equivalent on 2023-01-09. Applicant: Icotec AG. Device class: 2.
Clearance details
- Applicant
- Icotec AG
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 9450 Altstaetten (Sg), CH
Recent devices under product code PML
view all- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
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 PML
product code PML- Death
- 8
- Total
- 8
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 K222789
K-number listed on FDA's recall record- Z-0700-2024 — VADER pedicle system, torque wrench, Catalog Number 42-702
- Z-0701-2024 — VADER pedicle system, torque wrench, Catalog Number 42-703
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222789.
Data sourced from openFDA. This site is unofficial and independent of the FDA.