Atlas FDA

VADER® Pedicle System, G21 Cement

FDA 510(k) clearance K222789 · decided 2023-01-09

Clearance details

K-number
K222789
Device name
VADER® Pedicle System, G21 Cement
Applicant
Icotec AG
Decision
Substantially Equivalent
Date received
2022-09-15
Decision date
2023-01-09
Days to decision
116 days
Clearance type
Traditional
Product code
PML
Device class
2
Regulation number
888.3027
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
9450 Altstaetten (Sg), CH
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Dynamo™ Spinal Cement; Salvo® Spine System (K260286)Spine Wave, Inc.2026-06-15
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252885)Astura Medical2026-01-22
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (K241034)Medacta International S.A.2024-06-12
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809)Ulrich Medical USA2023-10-20
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774)Spineart2023-06-23
Invictus® Bone Cement, Invictus Spinal Fixation System (K221926)Alphatec Spine, Inc.2022-12-20
BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256)Neo Medical SA2022-08-26
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489)Neo Medical SA2021-10-28
G21 Cement, VADER® Pedicle System (K200596)Icotec AG2020-10-13
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362)Medtronic2020-08-19
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818)Stryker Corporation2020-03-31
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526)CarboFix Orthopedics , Ltd.2019-09-19

Recalls involving this device

RecordFirmDate
VADER pedicle system, torque wrench, Catalog Number 42-702 recall (Z-0700-2024)Icotec Ag2024-01-10
VADER pedicle system, torque wrench, Catalog Number 42-703 recall (Z-0701-2024)Icotec Ag2024-01-10